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Siemens Healthcare Diagnostics Inc

Siemens Healthcare Diagnostics Inc Recalls

All product recalls associated with Siemens Healthcare Diagnostics Inc.

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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 841–860 of 4747 recalls

Epoc Host 2 (Siemens) – Quality Control Pressure (2022)

pO2 High Recovery in Quality Control When Adjusted for Barometric Pressure

FDADec 12, 2022Nationwide• Siemens Healthcare Diagnostics Inc

Cobas Infinity Central Lab (Roche) – Order Rejection Issue (2022)

A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.

FDADec 12, 2022Nationwide• Roche Diagnostics Operations, Inc.

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Rifampin Capsules (Lupin) – Impurity Specifications (2022)

Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.

Class IIModerate

FDADec 12, 2022Nationwide• Lupin Pharmaceuticals Inc.

Neuroquell Plus Homeopathic Drug (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

ProSirona Homeopathic Formula (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

Neuroquell Homeopathic Drug (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

Menastil Homeopathic Formula (Atlantic) – cGMP Issues (2022)

cGMP Deviations

Class IIModerate

FDADec 12, 2022Nationwide• Atlantic Management Resources Ltd.

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples

FDADec 7, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Quinapril Tablets 40mg (Lupin) – Impurity Limit Exceeded (2022)

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Class IIModerate

FDADec 7, 2022Nationwide• Lupin Pharmaceuticals Inc.

Quinapril Tablets 20mg (Lupin) – Impurity Limit Exceeded (2022)

CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Class IIModerate

FDADec 7, 2022Nationwide• Lupin Pharmaceuticals Inc.

IMMULITE 2000 Thyroglobulin (Siemens) – Sensitivity Issue (2022)

FDADec 7, 2022Nationwide• Siemens Healthcare Diagnostics, Inc.

Lacosamide Oral Solution (Camber) – Excipient Specification Fail (2022)

Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content

Class IIILow

FDADec 6, 2022Nationwide• Camber Pharmaceuticals, Inc

STAT-IntraOp Immunoassay Kit (Future Diagnostics) – High Variability (2022)

Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

FDADec 6, 2022AZ, CA, CO +4 more• Future Diagnostics Solutions B.V. Nieuweweg 279 Wijchen Netherlands

Oxcarbazepine Tablets 600mg (Sun Pharma) – Foreign Substance (2022)

Presence of foreign substance

Class IIModerate

FDADec 1, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Desmopressin Acetate Tablets (Heritage) – Subpotent Drug (2022)

Subpotent Drug

Class IIModerate

FDANov 23, 2022Nationwide• Heritage Pharmaceuticals Inc

VITROS PTH Reagent Pack (Ortho-Clinical) – Result Bias (2022)

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

FDANov 17, 2022Nationwide• Ortho-Clinical Diagnostics, Inc.

Daytrana (Noven) – Defective Adhesive System (2022)

Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.

Class IIModerate

FDANov 16, 2022Nationwide• Noven Pharmaceuticals Inc

Hass Avocados (Four Seasons) – Safety Concern (2022)

Sunrise Logistics Inc/ Four Seasons Produce Inc, 400 Wabash , Road Ephrata, PA 17522 has initiated a recall of, PROPAL Hass Avocados, Bag of 6 pieces, Green net with green plastic film, 11 bags per case because they were found to be contaminated with pesticides as per tolerance limit 40CFR 180.275.

Class IIILow

FDANov 15, 2022IN, NJ, PA• Four Seasons Produce Warehouse #2/Sunrise Logistics, Inc

Sodium Sulfacetamide Cleansing Pads (Acella) – Subpotent Drug (2022)

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC

Phenytoin Sodium Injection (Acella) – Missing Barcode (2022)

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

Class IIILow

FDANov 14, 2022Nationwide• Acella Pharmaceuticals, LLC