Reported Oct 16, 2019 · Terminated
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
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?
- Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190
- Analyzer/Modulecobas c 311 and cobas c 501/502
- Lot codes and dates
- All Lots
- Amount recalled
- 27676 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Inaccurately Low Sample Results
This product could cause temporary or reversible health problems — stop using it.
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