Roche Diagnostics Operations, Inc. recalls Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

Recalled October 16, 2019 · FDA recall Z-0042-2020 · Roche Diagnostics Operations

Hazard

Inaccurately Low Sample Results · FDA Class II

Units

27676 units

Sold at

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Description

Inaccurately Low Sample Results

Product

Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502

Manufacturer(s)

Roche Diagnostics Operations, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →