Public recall detail

Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce)

2022-12-14

medium
Recall Safety notice
Quick summary

Quick summary: Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce). Date: 2022-12-14.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Alinity M Resp-4-Plex Amplification (Amp) Kit (Ce). Date: 2022-12-14.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandAbbott Molecular Inc.
ProductAlinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72335

Affected products

ProductAlinity M Resp-4-Plex Amplification (Amp) Kit (Ce)
Lot526393 525766 381177 527142 525460 531612 526483 527602 527403
Model03R1120 03R1130 506-10 506-30
Serial number526393 525766 381177 527142 525460 531612 526483 527602 527403
DescriptionAlinity M Resp-4-Plex Amplification (Amp) Kit (Ce)

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

What you should do

  • Contact the manufacturer fi you require additional information.
Additional official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Medical devices
CompaniesAbbott Molecular Inc. 1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-72335
Background{}
CompaniesAbbott Molecular Inc. 1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018
AudiencesGeneral public Healthcare Industry
Source updated2022-12-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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