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Architect i system - stat myoglobin assay
Official notice
14 Mar 2022
Last checked
14 Mar 2022
An official Health Canada notice concerns Architect i system - stat myoglobin assay. 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 Published 2022-03-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63999
Official notice
2022-03-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Abbott Laboratories Diagnostics Division, Architect I System - Stat Myoglobin Assay.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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