Health product recall

Architect "I" System - Stat Myoglobin Assay

Last updated

Summary

Product
Architect "I" System - Stat Myoglobin Assay
Issue
Medical devices - Unauthorised device
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Architect "I" System - Stat Myoglobin Assay

166000

2K43-01

Issue

The purpose of this recall is to inform the customer of a product recall for architect stat myoglobin calibrators, ln 2k43-01, lot number 166000. They have identified that this calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the instructions for use (IFU).

Recall start date: Mar 10, 2022

Additional information

Details
Original published date: 2022-03-17
Alert / recall type
Health product recall
Category
Health product - Medical device - Chemistry
Companies

Abbott Laboratories Diagnostics Division

100 Abbott Park Road, Abbott Park, Illinois

United States, 60064

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63999