Alinity m Resp-4-Plex Amplification recall
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction…
Why was Alinity m Resp-4-Plex Amplification 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: 00884999049338; Lot Numbers: 409383 410627 411921
- Product
- Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction…
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 1447 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- May 21, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)