Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Test Results
Abbott Molecular is recalling specific lots of the Alinity m Resp-4-Plex Amp Kit due to reports of false positive and false negative test results.
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 recall of a diagnostic device associated with false positive and false negative test results that pose a risk of patient harm through incorrect diagnoses. No illnesses, injuries, or deaths have been reported in the source material.
Plain-English summary
Abbott Molecular, Inc. is recalling the Abbott Alinity m Resp-4-Plex Amp Kit (Part Number 09N79-096) in certain lots due to reports of an increase in reactive negative controls and false positive results.
The affected product is a molecular amplification kit used in laboratory diagnostic testing. Three thousand eight hundred ninety-six kits were distributed worldwide. The affected lot numbers are: 381465 (expiration 8/24/2023), 524433 (expiration 1/5/2023), 526710 (expiration 1/21/2023), and 527845 (expiration 2/8/2023).
These false positive and false negative results could affect the accuracy of diagnostic tests performed with this product.
The recalled product
- Product
- Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
- Manufacturer
- Abbott Molecular, Inc.
- Affected units
- 3,896
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: 381465
- exp 8/24/2023
- 524433
- exp 1/5/2023
- 526710
- exp 1/21/2023
- 527845
- exp 2/8/20231499
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Abbott Molecular, Inc. 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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