Roche Online TDM Vancomycin Gen.3 Recalled for Inaccurate Low Sample Results
Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 kits because they may produce inaccurately low sample results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II, and the hazard involves inaccurate test results which pose a risk of harm to patients, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Online TDM Vancomycin Gen.3 (200 tests) product, Catalog # 06779344190, used with the cobas c 311 and cobas c 501/502 analyzers. The recall was initiated because the product may produce inaccurately low sample results.
The recall covers 33,979 units distributed to 48 states, the District of Columbia, Puerto Rico, and Guam. All lots are affected. The source text does not specify the exact dates of distribution or the specific facilities where the product was used.
Healthcare facilities and laboratories should stop using the affected product and contact Roche Diagnostics for further instructions. The source text does not provide specific consumer instructions for individual patients, as this is a professional medical device.
The recalled product
- Product
- Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 33,979
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)
- All Lots
Distribution
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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