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Siemens Healthcare Diagnostics

Siemens Healthcare Diagnostics Recalls

All product recalls associated with Siemens Healthcare Diagnostics.

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3841–3860 of 4747 recalls

Siemens Healthcare Diagnostics: ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADV...

The ADVIA Chemistry Systems A1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (Hb)A1c samples when using A1c_3 Calibrator lots 3HD044 and 3LD068. Depending on quality control limits, this issue may not have been detected. NOTE: The percent bias range is a percentage of the HbA1c result. It is NOT absolute HbA1c units.

Class IIModerate

FDAAug 6, 2014Nationwide• Siemens Healthcare Diagnostics

Children's Q-PAP Cherry Acetaminophen Suspension (Qualitest) – Superpotent Drug (2014)

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Class IIModerate

FDAAug 6, 2014Nationwide• Qualitest Pharmaceuticals

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Children's Q-PAP Acetaminophen Suspension (Qualitest) – Superpotent Drug (2014)

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Class IIModerate

FDAAug 6, 2014Nationwide• Qualitest Pharmaceuticals

Children's Q-PAP Bubble Gum Acetaminophen Suspension (Qualitest) – Superpotent Drug (2014)

Superpotent Drug: Qualitest Pharmaceuticals is initiating a recall of three flavors of Acetaminophen Oral Suspension Liquid 160mg/5mL for failure of the product assay at the 12 month timepoint.

Class IIModerate

FDAAug 6, 2014Nationwide• Qualitest Pharmaceuticals

Atenolol Tablets (Zydus) – Superpotent Drug Concern (2014)

Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance.

Class IIModerate

FDAAug 5, 2014Nationwide• Zydus Pharmaceuticals USA Inc

Cubicin (Cubist) – Glass Particulate Contamination (2014)

Presence of Particulate Matter: Potential presence of glass particulate matter in the vials.

Class IHigh

FDAAug 1, 2014Nationwide• Cubist Pharmaceuticals, Inc.

Roche Diagnostics Operations, Inc.: Roche cobas IT 1000 Product Usage: Intended Use: An e...

Potential that test results would be assigned to the wrong Patient ID if cobas IT 1000 receives an ADT ADMIT, TRANSFER or MERGE event message that contains a genuine Patient ID (e.g. 999999), which is the same as what has been configured as the Generic Patient ID (999999 by default).

Class IIModerate

FDAJul 31, 2014Nationwide• Roche Diagnostics Operations, Inc.

Cataflam (Novartis) – illegible tablet markings (2014)

Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers.

Class IIILow

FDAJul 30, 2014Nationwide• Novartis Pharmaceuticals Corp.

Philips Healthcare Informatics, Inc.: Philips IntelliSpace PACS 4.4 image management systems pe...

A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the potential for diagnosis on incomplete data.

Class IIModerate

FDAJul 24, 2014Nationwide• Philips Healthcare Informatics, Inc.

Sterile Products (Unique) – sterility assurance issues (2014)

Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products intended to be sterile.

Class IIModerate

FDAJul 18, 2014Nationwide• Unique Pharmaceutical, Ltd

Diagnostica Stago, Inc.: Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA ...

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Class IIILow

FDAJul 18, 2014Nationwide• Diagnostica Stago, Inc.

N-Acetyl Cysteine (Unique) – bacterial contamination (2014)

Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense.

Class IHigh

FDAJul 18, 2014Nationwide• Unique Pharmaceutical, Ltd

Clonidine HCl Injection (X-Gen) – labeling error (2014)

Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride".

Class IIILow

FDAJul 17, 2014Nationwide• X-Gen Pharmaceuticals Inc.

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension EXL Integrated Chemistry System in vitr...

The Reagent Lid hinge may lose its effectiveness and slowly shift downward during maintenance procedures, potentially resulting in physical contact and injury to the operator.

Class IIModerate

FDAJul 16, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

ORTHO-CLINICAL DIAGNOSTICS: VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and...

Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.

Class IIModerate

FDAJul 16, 2014Nationwide• ORTHO-CLINICAL DIAGNOSTICS

Siemens Healthcare Diagnostics, Inc.: Siemens Dimension Chemistry Wash (RD701) is an accessory ...

Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI (RF521C); Free T4, FT4 (RF410); Thyroid Stimulating Hormone, TSH (RF412); and N-terminal pro-brain natriuretic peptide, PBNP (RF423A) and LPBN (RF523A) when using Dimension® Chemistry Wash lot RD41041. Internal inv

Class IIModerate

FDAJul 15, 2014Nationwide• Siemens Healthcare Diagnostics, Inc.

Ortho-Clinical Diagnostics: VITROS¿ Chemistry Products CDM PROM Calibration Data Modu...

Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.

Class IIModerate

FDAJul 15, 2014IL, KY, MA +4 more• Ortho-Clinical Diagnostics

Daytrana Patch (Noven) – delivery system defect (2014)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.

Class IIModerate

FDAJul 15, 2014Nationwide• Noven Pharmaceuticals, Inc.

Losartan Potassium Hydrochlorothiazide Tablets (Jubilant) – Metal Contamination (2014)

Presence of Foreign Substance: Tablets may contain dark blemishes identified as stainless steel.

Class IIModerate

FDAJul 11, 2014Nationwide• Jubilant Cadista Pharmaceuticals Inc.

Triamcinolone Acetonide Lotion 0.1% (Fougera) – pH Specification Issue (2014)

Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.

Class IIILow

FDAJul 3, 2014Nationwide• Fougera Pharmaceuticals Inc.