Reported Aug 11, 2021 · Ongoing
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
Abbott Laboratories
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: Abbott Laboratories · 1915 Hurd Dr · Irving, TX · 75038
Is this the product you have?
- REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE
- UDI(01) 00380740017866
- Lot codes and dates
- Lot Numbers / Expiration Date 15014UN20 20OCT2021 09153UN21 09MAR2022 *Not distributed within the US.
- Amount recalled
- 36 units
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
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
This product could cause temporary or reversible health problems — stop using it.
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