Roche Vancomycin Test Recall Due to Inaccurate Low Results
Roche Diagnostics is recalling Online TDM Vancomycin Gen.3 tests 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 involves a medical device that may produce inaccurate results, posing a risk of harm to patients through incorrect dosing, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Online TDM Vancomycin Gen.3 (100 tests) product, catalog number 06779336190. This product is used with the cobas c 311 and cobas c 501/502 analyzers. The recall involves 27,676 units distributed across 47 states, the District of Columbia, Puerto Rico, and Guam.
The recall was initiated because the product may produce inaccurately low sample results. This issue could potentially affect the accuracy of therapeutic drug monitoring for vancomycin.
Healthcare facilities and laboratories that have this product should stop using it and contact Roche Diagnostics for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 27,676
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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