Siemens Healthcare Diagnostics Inc recalls

48 recalls on record · latest: April 2, 2026

Official U.S. recall history for Siemens Healthcare Diagnostics Inc, compiled from official government records.

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Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;

April 2, 2026 · Medical device recalls Moderate risk Use of the affected product can result in discrepant low pH and measured Total…

Siemens Healthcare Diagnostics, Inc. recalls Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.

March 18, 2026 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinin…

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

February 23, 2026 · Medical device recalls Moderate risk A potential for depressed results for Atellica CH A1c_E when processing Atellic…

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225

January 20, 2026 · Medical device recalls Moderate risk Falsely depressed UAlb patient results may occur. Affected samples with any uri…

IMMULITE 2000 Oak Mix Specific Allergen recalled over undeclared allergens

October 6, 2025 · Medical device recalls Moderate risk The barcode orientation on affected devices causes incorrect scanning order of…

3gAllergy Specific IgE Universal Kit recalled over undeclared allergens

October 6, 2025 · Medical device recalls Moderate risk The barcode orientation on affected devices causes incorrect scanning order of…

Food Panel 3 Specific Allergen recalled over undeclared allergens

October 6, 2025 · Medical device recalls Moderate risk The barcode orientation on affected devices causes incorrect scanning order of…

Siemens Healthcare Diagnostics, Inc. recalls Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Num…

September 22, 2025 · Medical device recalls Moderate risk The potential for falsely depressed Intact PTH patient results at the low end o…

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.

August 11, 2025 · Medical device recalls Moderate risk Potential for falsely depressed patient, quality control (QC), and/or calibrati…

Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.

July 7, 2025 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias m…

Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.

June 26, 2025 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Was…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i SETpoint Calibrator

June 4, 2025 · Medical device recalls Moderate risk Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)

June 4, 2025 · Medical device recalls Moderate risk Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)

June 4, 2025 · Medical device recalls Moderate risk Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)

June 4, 2025 · Medical device recalls Moderate risk Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/…

Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;

May 22, 2025 · Medical device recalls Moderate risk Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact ca…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

April 15, 2025 · Medical device recalls Moderate risk Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calib…

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

April 15, 2025 · Medical device recalls Moderate risk Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calib…

Siemens Healthcare Diagnostics Inc recalls Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.

March 31, 2025 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care c…

Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736382; epoc Soft…

March 19, 2025 · Medical device recalls Moderate risk The occurrence of discrepant high pH results in samples introduced with higher…

Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Softw…

March 19, 2025 · Medical device recalls Moderate risk The occurrence of discrepant high pH results in samples introduced with higher…

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

March 11, 2025 · Medical device recalls Moderate risk Incorrect software flagging may occur for the assay that may potentially lead t…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9. Intended for use by t…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Intended for use by train…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Intended for use by train…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Intended for use by train…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by train…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. Intended for use by tra…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Intended for use by train…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Intended for use by train…

November 22, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System be…

Siemens Healthcare Diagnostics, Inc. recalls Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;

November 12, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿…

Siemens Healthcare Diagnostics, Inc. recalls Atellica CI Analyzer. Catalog Numbers: 10947347.

November 4, 2024 · Medical device recalls Moderate risk Potential that the IMT Diluent volume remaining (% remaining) does not decrease…

Siemens Healthcare Diagnostics, Inc. recalls Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of ¿2-microglobulin in…

October 21, 2024 · Medical device recalls Moderate risk Potential for falsely depressed auto-diluted results for samples above the meas…

Siemens Healthcare Diagnostics, Inc. recalls Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes an…

October 21, 2024 · Medical device recalls Moderate risk A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with l…

Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

September 30, 2024 · Medical device recalls Moderate risk The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi…

Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

September 24, 2024 · Medical device recalls Moderate risk Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias m…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)

August 21, 2024 · Medical device recalls Moderate risk Positive bias in patient results at and below the cut-off of 60 U/mL with the l…

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)

August 21, 2024 · Medical device recalls Moderate risk Positive bias in patient results at and below the cut-off of 60 U/mL with the l…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in…

August 15, 2024 · Medical device recalls Moderate risk Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿AL…

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in huma…

August 15, 2024 · Medical device recalls Moderate risk Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿AL…

Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista¿ Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 10445146;

July 30, 2024 · Medical device recalls Moderate risk During manufacturing, the last three tests from the 160 test flex of lot 23206B…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151

July 29, 2024 · Medical device recalls Moderate risk The potential for biased quality control (QC) and patient results when using At…

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

July 29, 2024 · Medical device recalls Moderate risk The potential for biased quality control (QC) and patient results when using At…

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated…

July 26, 2024 · Medical device recalls Moderate risk Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associate…

July 26, 2024 · Medical device recalls Moderate risk Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U…

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-assoc…

July 26, 2024 · Medical device recalls Moderate risk Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U…

Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated…

July 26, 2024 · Medical device recalls Moderate risk Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U…

Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated a…

July 26, 2024 · Medical device recalls Moderate risk Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U…