The Recall Desk
HighFDA (Devices)·Z-2184-2021·Announced 2021-08-11

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.

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 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
Category
Medical Device — Laboratory / Diagnostic Reagent
Hazard
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

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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.

See all 4 products in this recall →

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