Mas CardioImmune Xl 1 2 3, Mas CardioImmune Xl L
Brand(s)
Summary
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
Microgenics Corporation
46500 Kato Road, Fremont, California, United States, 94538
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