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Health Canada Medical devices

Architect "I" System - Stat Myoglobin Assay

Issued March 14, 2022
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
Hazard description
Unauthorised device
Product
Product name
Architect "I" System - Stat Myoglobin Assay
Reference
ID
RA-63999