Reported Oct 2, 2024 · Ongoing
Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative…
Roche Diagnostics Operations, Inc.
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: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma
- Catalog Number07190794190
- Lot codes and dates
- UDI-DI04015630940806
- Lot Number755471 Exp
- Date06/30/2024
- Amount recalled
- 6504 units
Where it was sold
- Nationwide
Why it was recalled
Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may lead to erroneous results and misdiagnosis.
This product could cause temporary or reversible health problems — stop using it.
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