FDAClass IIDecember 28, 2022

Abbott Alinity m Resp-4-Plex Amp Kit recall

Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

Why was Abbott Alinity m Resp-4-Plex Amp Kit recalled?

Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits.

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?

Lot Numbers: 381465, exp 8/24/2023; 524433, exp 1/5/2023; 526710, exp 1/21/2023; 527845, exp 2/8/20231499

Product
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Recalling firm
Abbott Molecular, Inc.
Quantity
3896 kits
Distribution
Worldwide
Recall date
December 28, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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