Mas CardioImmune Xl 1 2 3, Mas CardioImmune Xl L
Brand(s)
Last updated
Summary
Product
Mas CardioImmune Xl 1 2 3, Mas CardioImmune Xl L
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Mas CardioImmune Xl 1 2 3, Mas CardioImmune Xl L | CXL25041 | CAI-XL 1 |
| Mas CardioImmune Xl 1 2 3, Mas CardioImmune Xl L | CXL25045 | CAI-XLS |
| Mas CardioImmune Xl 1 2 3, Mas CardioImmune Xl L | CXL25044 | CAI-XL4 |
Issue
Manufacturer initiated recall notifying users of variability of only the level 1 troponin I values included in the Mas CardioImmune XL controls (confirmed after 8 complaints). The level 1 control is included in lots of control kits CAI-XL 1, CAI-XL4 and CAI-XLS. This variability may lead some vials to recover higher than expected values, therefore manufacturer directs user to not use troponin I values for level 1 (other constituents in level 1 are not affected).
Recall start date: January 5, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Microgenics Corporation
46500 Kato Road, Fremont, California, United States, 94538
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-72612
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