Roche Recalls Vancomycin Assay Kits Due to Incorrect Method Sheets
Roche Diagnostics is voluntarily recalling Vancomycin assay kits because method sheets contain incorrect comparison data for specific analyzers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states it is a voluntary recall due to documentation errors (incorrect method sheets) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. has issued a voluntary recall for the Online TDM Vancomycin assay kits. The affected products include the ONLINE TDM Vancomycin 100 tests, ONLINE TDM Vancomycin 200 tests, Hitachi Vancomycin (Modular P), and Hitachi Vancomycin (917, MOD P). These assays are used for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry analyzers.
The recall was initiated because the method sheets provided with these kits state an incorrect method comparison against the COBAS INTEGRA 800 analyzer. This documentation error affects the kits used on the cobas c 311/501/502 analyzers and the Modular Analytics P module.
A total of 53,897 units were distributed nationwide to 49 states and Puerto Rico. The source text does not report any illnesses or injuries associated with this recall. Healthcare facilities and laboratories should stop using the affected kits and contact the manufacturer for further instructions.
The recalled product
- Product
- ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modular P); Hitachi Vancomycin (917, MOD P) The ONLINE TDM Vancomycin assay is for the quantitative determination of Vancomycin in human serum or plasma on Roche automated clinical chemistry
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 53,897
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)
- MOD P)
Distribution
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