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Beckman Coulter Inc.

Beckman Coulter Inc. Recalls

All product recalls associated with Beckman Coulter Inc..

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Recall Summary

Total Recalls

1000

Past Year

567

Class I (Serious)

Most Recent

Jan 2026

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 2601–2620 of 7756 recalls

Beckman Coulter Inc.: ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X ...

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

FDAJul 1, 2021Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: ...

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

FDAJul 1, 2021Nationwide• Beckman Coulter Inc.

Beckman Coulter Inc.: ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UD...

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

FDAJul 1, 2021Nationwide

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• Beckman Coulter Inc.

Beckman Coulter Inc.: Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C6...

SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .

FDAJul 1, 2021Nationwide• Beckman Coulter Inc.

BAXTER HEALTHCARE CORPORATION: Sharesource Connectivity Platform for Use with the Amia A...

Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

FDAJun 30, 2021Nationwide• BAXTER HEALTHCARE CORPORATION

BAXTER HEALTHCARE CORPORATION: Kaguya Automated Peritoneal Dialysis System

FDAJun 30, 2021Nationwide• BAXTER HEALTHCARE CORPORATION

Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France: The Aequalis Pyrocarbon Humeral Heads. Shoulder implant ...

Potential patient exposure to the graphite substrate.

FDAJun 25, 2021CA, CO, CT +12 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot St Martin France

Beckman Coulter, Inc.: Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 an...

Software anomalies that may lead to the generation of erroneous results.

FDAJun 23, 2021Nationwide• Beckman Coulter, Inc.

BioMerieux SA Chemin De L'Orme Marcy L'Etoile France: MYLA software. Used to manage microbiology test workflow...

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

FDAJun 22, 2021Nationwide• BioMerieux SA Chemin De L'Orme Marcy L'Etoile France