Abbott Alinity m Resp-4-Plex Amp Kit Recalled for False Positive Results
Abbott Molecular is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit due to reports of false positive results and reactive negative controls. No illnesses or injuries have been reported.
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 a Class II recall of a diagnostic test kit with reported false positive results and negative control failures. No illnesses or injuries have been reported. The hazard involves test accuracy defects that could potentially lead to patient harm through misdiagnosis, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Abbott Molecular, Inc. is recalling approximately 12,116 units of the Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090, distributed worldwide.
The FDA issued a Class II recall due to reports of an increase in reactive negative controls and false positive results affecting certain lots of the kit. These issues can compromise the accuracy of diagnostic test results.
Affected lot numbers include 381177 (expiration date 8/24/2023) and additional lots. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
- Manufacturer
- Abbott Molecular, Inc.
- Hazard
- false-positives
- negative-control-failure
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 (11)
- Lot Numbers: 381177
- exp 8/24/2023
- 525460
- exp
- 525766
- 526393
- 526483
- 527142
- 527403
- 527602
- 531612
Distribution
Distribution scope not specified by the agency.
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