Abbott Activated Alanine Aminotransferase Reagent Accuracy Issue Recall
Abbott's A-ALT laboratory reagent may produce inaccurate results in samples with very high enzyme levels or elevated bilirubin, potentially affecting patient diagnoses. The affected product (REF 8L92-21) was distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 diagnostic device recall with potential to produce inaccurate test results that could affect clinical decisions. The hazard is theoretical with no reported illnesses, injuries, or hospitalizations, meeting the rubric criterion for High severity as a risk-of-harm medical device where injury has not yet been reported.
Plain-English summary
Abbott Laboratories is recalling its Activated Alanine Aminotransferase (A-ALT) laboratory reagent, REF 8L92-21, for use with the Architect analyzer. The reagent may produce inaccurate results in two specific scenarios: samples with A-ALT values greater than 1,200 U/L may show under-recovery greater than 10%, and samples with bilirubin concentrations greater than 31 mg/dL may show result shifts greater than 10%. These inaccuracies could lead to incorrect patient test results.
The affected reagent was distributed worldwide. In the United States, distribution included California, Idaho, Maine, New York, Pennsylvania, South Dakota, Tennessee, Texas, Utah, and Virginia. The reagent was also distributed internationally to countries including Australia, Austria, Bangladesh, Belgium, Canada, the United Kingdom, China, India, Israel, Mexico, and numerous others. Lot numbers affected are 15014UN20 (expiring 20 October 2021) and 09153UN21 (expiring 9 March 2022).
No illnesses or injuries related to this recall have been reported.
The recalled product
- Product
- REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
- Manufacturer
- Abbott Laboratories
- Affected units
- 36
Distribution
Part of a larger recall action
This product is one of 4 recalled by Abbott Laboratories under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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