ARCHITECT Anti-HCV Reagent Kit Recalled for False Positive Results
Abbott GmbH is recalling ARCHITECT Anti-HCV Reagent Kit (7,219 units) due to falsely elevated test results when processed after certain other tests on the same instrument. The product was distributed nationwide.
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 recall where falsely elevated diagnostic test results represent a risk of patient harm through misdiagnosis. However, no illnesses, injuries, or hospitalizations have been reported, keeping the severity at the High level rather than Severe per the rubric.
Plain-English summary
The ARCHITECT Anti-HCV Reagent Kit is a laboratory diagnostic reagent used in clinical settings. Abbott GmbH is recalling specific lot numbers due to falsely elevated test results.
Customer complaints revealed that some patient samples produced falsely elevated results. Abbott's internal studies with returned samples confirmed that potential interactions can occur when Anti-HCV testing is performed immediately after other specific tests on the same instrument: either ARCHITECT Syphilis TP or ARCHITECT AdviseDx SARS-CoV-2-IgG II tests. Similar interactions have also been identified on Alinity i instruments when Syphilis TP testing precedes Anti-HCV testing.
The recall affects 7,219 units of product list numbers 1L79-25 and 1L79-35, distributed nationwide in the United States. Specific lot numbers have been identified for each product variant.
The recalled product
- Product
- ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
- Manufacturer
- Abbott GmbH
- Affected units
- 7,219
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 (14)
- a) 1L79-25
- 00380740001414
- Lot Numbers: 52011BE00
- 54140BE00
- 56375BE00
- 58163BE00
- 59194BE00
- b) 1L79-35
- 00380740001421
- Lot Numbers: 52015BE00
- 54144BE00
- 56379BE00
- 58167BE00
- 59198BE00
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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