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 products - Medical devices - 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