Reported Sep 30, 2020 · Terminated
BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
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?
- BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
- Lot codes and dates
- Catalog Number33570
- UDI Code(01)15099590231187
- Serial/Lot Numbers921133 921348 921742
- Amount recalled
- 21455 assay systems
Where it was sold
Why it was recalled
Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
This product could cause temporary or reversible health problems — stop using it.
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