Public recall detail

Alinity and Architect A1C Reagent Kit

2022-06-23

medium
Recall Safety notice
Quick summary

Quick summary: Alinity and Architect A1C Reagent Kit. Date: 2022-06-23.

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 and Architect A1C Reagent Kit. Date: 2022-06-23.

Official details

Affected product details

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

BrandAbbott Gmbh
ProductAlinity and Architect A1C Reagent Kit
IssueMedical devices - Performance
Recall classType II
IdentificationRA-64283

Affected products

ProductAlinity C Hemoglobin A1C Reagent Kit
Lot61658UQ01 59779UQ05 60229UQ07 61011UQ10 61349UQ01 60540UQ09 59561UQ04
Model08P4320
Serial number61658UQ01 59779UQ05 60229UQ07 61011UQ10 61349UQ01 60540UQ09 59561UQ04
DescriptionAlinity C Hemoglobin A1C Reagent Kit
ProductArchitect Hemoglobin A1C Reagent
Lot60535UQ08 59588UQ04 61066UQ11 59868UQ05 60237UQ08 60698UQ09 60880UQ10 61246UQ01 60138UQ07 61250UQ01 59900UQ06
Model4P52-20
Serial number60535UQ08 59588UQ04 61066UQ11 59868UQ05 60237UQ08 60698UQ09 60880UQ10 61246UQ01 60138UQ07 61250UQ01 59900UQ06
DescriptionArchitect Hemoglobin A1C Reagent

Issue

This recall is to inform of a potential for falsely elevated hemoglobin %A1C and hemoglobin A1C patient results to be generated using the architect hemoglobin A1C assay when analyzing whole blood or hemolysate samples with poor sample integrity, due to micro-clots and particulate matter, associated with low total hemoglobin values. to address this issue, a revision to the total hemoglobin low linearity value for the architect hemoglobin a1c whole blood and hemolysate applications has been implemented. Recall start date: June 15, 2022

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - Chemistry
CompaniesAbbott GmbH Max-Planck-Ring 2, Wiesbaden, Germany, 65205
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-64283
Background{}
CompaniesAbbott GmbH Max-Planck-Ring 2, Wiesbaden, Germany, 65205
AudiencesHealthcare Industry
Source updated2022-06-20

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

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...