Reported Dec 10, 2014 · Terminated
MAS CardioImmune XL Cardiac Marker Control; Model: CAI-XL1; intended for use in the clinical laboratory as an assayed…
Microgenics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microgenics Corporation · 46500 Kato Road · Fremont, CA · 94538
Is this the product you have?
- MAS CardioImmune XL Cardiac Marker Control
- ModelCAI-XL1; intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determinations
- Lot codes and dates
- Model No.: CAI-XL1
- Lot NumberCXL16011, Exp
- Date2016-01-31
- Amount recalled
- 2135 vials.
Where it was sold
Why it was recalled
MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32).
This product could cause temporary or reversible health problems — stop using it.
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