Abbott Activated Alanine Aminotransferase Reagent May Produce Inaccurate Patient Results
Abbott's A-ALT diagnostic reagent may produce inaccurate test results for samples with elevated enzyme or bilirubin levels, potentially affecting patient outcomes. The affected reagent kits have been distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II in vitro diagnostic recall with potential for inaccurate patient test results that could affect treatment decisions. No reported illnesses or injuries to date, placing this in the high-risk category for products where injury has not yet been reported.
Plain-English summary
Abbott Laboratories is recalling certain lots of its Activated Alanine Aminotransferase (A-ALT) diagnostic reagent (REF 8L92-42), used with Architect laboratory analyzers.
The affected reagent lots may produce inaccurate test results in two scenarios. The reagent may show greater than 10% under-recovery for samples with alanine aminotransferase levels above 1,200 units per liter, producing false low results. Additionally, the reagent may display a greater than 10% shift in results for samples containing bilirubin concentrations above 31 milligrams per deciliter. These inaccuracies could lead to incorrect patient results.
The recall involves 2,212 units with distribution in the United States (including Virginia, Utah, Texas, Tennessee, South Dakota, Pennsylvania, New York, Maine, Idaho, and California) and numerous countries worldwide.
The affected lot numbers are: 84126UN20 (expires 09JUL2021), 03676UN20 (expires 25AUG2021), 10597UN20 (expires 29AUG2021), 26275UN20 (expires 20OCT2021), 77748UN20 (expires 08DEC2021), 65958UN20 (expires 08DEC2021), and 81824UN21 (expires 16FEB2022).
The recalled product
- Product
- REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
- Manufacturer
- Abbott Laboratories
- Hazard
- test-inaccuracy
- under-recovery
- bilirubin-interference
Distribution
Distributed nationwide across the United States.
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