Abbott Alinity c Reagent Kit Recall Due to Potential Test Result Errors
Abbott Laboratories is recalling its Alinity c Activated Alanine Aminotransferase reagent kit due to potential analytical errors that could produce incorrect test results. The issue affects certain lot numbers 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: This is an FDA Class II medical device recall involving analytical performance errors in a laboratory diagnostic reagent. No illnesses or injuries have been reported; the hazard is potential rather than confirmed. However, a diagnostic reagent that can produce inaccurate test results qualifies as a risk-of-harm product where clinical decision-making could be affected by incorrect enzyme measurements.
Plain-English summary
Abbott Laboratories is recalling 4,727 units of its Alinity c Activated Alanine Aminotransferase (A-ALT) reagent kit, used in laboratory blood testing. The affected lot numbers are: 83459UN20, 03168UN20, 09787UN20, 37977UN20, 63000UN20, 77745UN20, 77743UN21, and 09237UN21, with expiration dates ranging from July 9, 2021 to April 9, 2022.
The recall was initiated due to two potential analytical issues with this reagent kit. First, samples with A-ALT levels greater than 1,200 U/L may show approximately 15% under-recovery, meaning the test may report lower values than the actual level. Second, samples with high bilirubin concentrations greater than 31 mg/dL may show shifts of greater than 10% in test results. Both issues could lead to inaccurate patient test results.
The affected reagent kits were distributed worldwide to testing laboratories. In the United States, distribution was confirmed in the following states: Virginia, Utah, Texas, Tennessee, South Dakota, Pennsylvania, New York, Maine, Idaho, and California. The product was also distributed internationally to numerous countries including Canada, Australia, India, China, and the United Kingdom.
Laboratories currently using these reagent kits should stop using affected lot numbers and contact Abbott Laboratories. Laboratory directors and medical professionals should consider the potential for inaccurate results from tests performed with these reagent lots and determine whether retesting of affected samples may be necessary.
The recalled product
- Product
- REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, UDI: (01) 00380740132569
- Manufacturer
- Abbott Laboratories
- Affected units
- 4,727
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot Numbers / Expiration Date 83459UN20 /09JUL2021
- 03168UN20 /25SEP2021
- 09787UN20 /24OCT2021
- 37977UN20 /01JAN2022
- 63000UN20 /01JAN2022
- 77745UN20 /08JAN2022
- 77743UN21 /02MAR2022
- 09237UN21 /09APR2022
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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