Reported Aug 18, 2021 · Terminated
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI:…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION
- CONTENTS6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only
- UDI(01)15099590743017
- Lot codes and dates
- All Lots
- Amount recalled
- 3,672 unitsin total
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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