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Empowered Diagnostics LLC

Empowered Diagnostics LLC Recalls

All product recalls associated with Empowered Diagnostics LLC.

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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 1041–1060 of 4747 recalls

Empowered Diagnostics LLC: CovClear COVID-19 Rapid Antigen Test, ATG 900-031

COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA.

FDADec 22, 2021Nationwide• Empowered Diagnostics LLC

Penicillin V Potassium Solution (Teva) – Subpotent (2021)

Subpotent

Class IIModerate

FDADec 16, 2021Nationwide• Teva Pharmaceuticals USA

Clobetasol Ointment (Taro) – Bacterial Contamination (2021)

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

Class IHigh

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Page 53 of 238Next

FDA

Dec 15, 2021

Nationwide

• Taro Pharmaceuticals U.S.A., Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products VersaTips, Catalog No. 6801715 ...

Laceration Risk

The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or reagent dispensed. In cases where the error is not detected and the affected results are not suppressed, clinical impact may include reduced drug dosage, or false positive or false negative results for bloodborne infectious disease assays when sample results are close to the cut-off value.

FDADec 10, 2021Nationwide• Ortho-Clinical Diagnostics, Inc.

Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin: THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA

This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. This Dunnage Case was shipped on 02-Dec-2021. Dunnage is used during the sterilization process and is not intended for customer use.

FDADec 10, 2021Nationwide• Mallinckrodt Pharmaceuticals Ireland Ltd College Business & Technology Park Blanchardstown Road North Dublin

Brinzolamide Suspension (Teva) – Defective Container (2021)

Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.

Class IIModerate

FDADec 8, 2021Nationwide• Teva Pharmaceuticals USA

Siemens Healthcare Diagnostics, Inc.: Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro ...

2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on patient samples of up to -10.5% at a B2M concentration of approximately 15 mg/L

FDADec 1, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.

Diclofenac Sodium Solution (Preferred) - Container Defect (2021)

Defective container: Out of specification for container integrity leading to bottles leaking.

Class IIModerate

FDANov 29, 2021CT, FL, IN +1 more• Preferred Pharmaceuticals, Inc.

Ortho-Clinical Diagnostics, Inc.: VITROS Immunodiagnostic Products High Sample Diluent A Re...

Lower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lot 2190.

FDANov 22, 2021Nationwide• Ortho-Clinical Diagnostics, Inc.

Hydrocodone Bitartrate Acetaminophen Tablets (Ascent Pharmaceuticals) – Product Mix-up (2021)

Product Mix-up

Class IIModerate

FDANov 19, 2021Nationwide• Ascent Pharmaceuticals, Inc.

Tydemy (Lupin Pharmaceuticals) – Subpotent Drug (2021)

Subpotent Drug

Class IIILow

FDANov 19, 2021Nationwide• Lupin Pharmaceuticals Inc.

Siemens Healthcare Diagnostics, Inc.: Atellica CH 930 Analyzer with Software version: V1.25.1 a...

(1)Software (SW) versions V1.25.1 and lower may result in TDef (Test Definition) Parameters for Open Channel Assays reverting to Default Value would shift test results by the magnitude of the implemented Assay Correlation factor; (2) On Board Stability (OBS) Not Updating with Manual Change for Open Channel Assays may continue to use the reagent past its expiration date leading to potential erroneous patient sample results

FDANov 18, 2021Nationwide• Siemens Healthcare Diagnostics, Inc.