Reported Jan 27, 2021 · Terminated
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems…
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 IgG QC SARS-CoV-2
- IgG REF C58964 - Product Usageuse on the Access Family of Immunoassay Systems only
- Lot codes and dates
- Catalog NumberC58964
- UDI Code15099590738662
- Lot Number922407
- Amount recalled
- 276 units
Where it was sold
Why it was recalled
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
This product could cause temporary or reversible health problems — stop using it.
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