Reported Mar 27, 2024 · Ongoing
Access Total T4, REF 33800, IVD, thyroxine reagent assay.
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. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
- Access Total T4, REF 33800, IVD, thyroxine reagent assay.
- Lot codes and dates
- Lot numbers
338555exp. 31 JUL 2024338556exp. 31 AUG 2024338734exp. 30 SEP 2024and 338958exp. 31 OCT 2024UDI-DI 15099590225742
- Lot numbers
- Amount recalled
- 64,009 kits
Where it was sold
Why it was recalled
Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results.
This product could cause temporary or reversible health problems — stop using it.
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