Alinity m Resp-4-Plex AMP Kit recall
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended…
Why was Alinity m Resp-4-Plex AMP Kit recalled?
There were reports of an increase in reactive negative controls and false positive results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00884929049390; Lot Number: 409384
- Product
- Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended…
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 656 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- May 21, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)