Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
Brand(s)
Last updated
Summary
Product
Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer fi you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce) | 526393 525766 381177 527142 525460 531612 526483 527602 527403 | 03R1120 03R1130 506-10 506-30 |
Issue
There is a potential for false positive results for flu B and RSV while using the list numbers and lot numbers referenced above associated with the manufacture of these lots. There is also a potential for delayed results when using these lots as reactive negative controls invalidate the sample run. Additional quality control mitigations have been put in place to prevent reoccurrence. All subsequent lots of Alinity m resp-4-plex amp kits are not impacted.
Recall start date: November 23, 2022
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies
Abbott Molecular Inc.
1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72335
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