Abbott Alinity i Anti-HCV Reagent Kit Recall for Falsely Elevated Test Results
Abbott is recalling the Alinity i Anti-HCV Reagent Kit (5110 units) due to potential false-positive test results when syphilis testing precedes the HCV test on the same instrument. Customer complaints and internal studies confirmed the interaction that may produce falsely elevated results.
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 device with confirmed defect causing inaccurate test results, but no reported illnesses or injuries. The hazard represents risk of harm through false positive diagnosis if results are relied upon without confirmation, meeting the criteria for High severity.
Plain-English summary
Abbott GmbH is recalling 5110 units of the Alinity i Anti-HCV Reagent Kit (List Number 08P0521, Lot Numbers 52020BE00, 54149BE00, 56384BE00, 58172BE00, 59203BE00) nationwide in the United States.
Abbott received customer complaints about falsely elevated results for some patient samples when testing was performed on the Alinity i instrument. The company conducted internal studies using returned samples and confirmed that a potential interaction occurs when certain tests are run immediately before the Anti-HCV test on the same instrument. Specifically, falsely elevated Anti-HCV results may occur when Alinity i Syphilis TP testing precedes Alinity i Anti-HCV testing. Similar interactions were also observed with ARCHITECT brand instruments when ARCHITECT Syphilis TP and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II testing precedes ARCHITECT Anti-HCV testing.
Falsely elevated Anti-HCV results could lead patients and healthcare providers to believe a patient is positive for Hepatitis C antibodies when they are not. Healthcare facilities using affected lot numbers should review recent test results and consider retesting patients where syphilis or SARS-CoV-2-IgG testing immediately preceded Anti-HCV testing on the same instrument. Patients who received testing during the affected period should consult with their healthcare provider about whether retesting is warranted.
The recalled product
- Product
- Alinity i Anti-HCV Reagent Kit, List Number 08P0521
- Manufacturer
- Abbott GmbH
- Affected units
- 5,110
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 (6)
- UDI/DI 00380740130657
- Lot Numbers: 52020BE00
- 54149BE00
- 56384BE00
- 58172BE00
- 59203BE00
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Abbott GmbH 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 2 products in this recall →Related recalls
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