Public recall detail

Alinity M System

2022-12-23

medium
Recall Safety notice
Quick summary

Quick summary: Alinity M System. Date: 2022-12-23.

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 System. Date: 2022-12-23.

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 System
IssueMedical devices - Performance
Recall classType II
IdentificationRA-72407

Affected products

ProductAlinity M System
LotAll lots.
Model08N53-002
Serial numberAll lots.
DescriptionAlinity M System

Issue

Abbott has identified three potential issues which may have impacted the amplification detection unit(s) (ADU) installed on your Alinity M system. 1. systems which had their ADU's serviced may have an incorrect boardvalue (calibration data file) referenced causing a misconfiguration of the calibration. 2. inability of maintenance and diagnostics 2300 (amp detect optical calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. under specific conditions during the adu manufacturing process, an incorrect calibration may potentially have been configured. Recall start date: December 13, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
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-72407
Background{}
CompaniesAbbott Molecular Inc. 1300 E. Touhy Ave., Des Plaines, Illinois, United States, 60018
AudiencesHealthcare
Source updated2022-12-23

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

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