Roche Creatine Kinase test reagents recalled for calibration errors
Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a diagnostic test with potential for erroneous results and misdiagnosis. However, the source documents no reported illnesses or injuries. Per the severity rubric, diagnostic device recalls with theoretical risk but no reported harm are classified as High.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling Creatine Kinase (CK) assay reagents (Catalog Number 07190794190, Lot Number 755471) for use with cobas c 311/501/502 and COBAS INTEGRA 400 plus analyzers. These in vitro diagnostic reagents are used in clinical laboratories to measure creatine kinase levels in human serum and plasma samples.
The recalled reagents may exhibit abnormal calibrations when used with the specified analyzers, causing the tests to produce erroneous results. This condition could lead to patient misdiagnosis.
The affected lot was distributed nationwide in the United States. The recall involves 6,504 units.
The recalled product
- Product
- 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 Number: 07190794190
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- calibration-error
- diagnostic-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04015630940806 Lot Number: 755471 Exp. Date: 06/30/2024
Distribution
Distributed nationwide across the United States.
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