Abbott Activated Alanine Aminotransferase Reagent Recalled for Inaccurate Test Results
Abbott is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) lab reagent due to potential inaccuracies in test results. High bilirubin or high A-ALT samples may produce incorrect results affecting patient care.
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: This is an FDA Class II diagnostic reagent recall involving potential for inaccurate test results that could affect patient care. No illnesses or injuries have been reported. Per the rubric, FDA Class II recalls without reported hospitalization or injury, where the hazard is potential rather than documented harm, are classified as High (3).
Plain-English summary
Abbott Laboratories is recalling 1,603 units of its Activated Alanine Aminotransferase (A-ALT) reagent (REF 8L92-22) for use with Architect laboratory systems. The affected lots were distributed worldwide, including the United States (Virginia, Utah, Texas, Tennessee, South Dakota, Pennsylvania, New York, Maine, Idaho, and California) and countries across Europe, Asia, the Middle East, Africa, and the Americas.
The recalled lots have a potential for greater than 10% under-recovery on A-ALT samples with concentrations greater than 1,200 U/L. Additionally, there is a potential for greater than 10% shift in patient results with samples containing bilirubin concentrations greater than 31 mg/dL. These issues could lead to incorrect patient results and may impact clinical decision-making.
The affected lot numbers and expiration dates are: 02954UN20 (29AUG2021), 37921UN20 (01DEC2021), and 81823UN21 (16FEB2022). Clinical laboratories using these lots should be aware of the potential for inaccurate results, particularly for samples with high A-ALT concentrations or high bilirubin levels.
The recalled product
- Product
- REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
- Manufacturer
- Abbott Laboratories
- Hazard
- diagnostic-inaccuracy
- test-interference
Distribution
Distributed nationwide across the United States.
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