Roche Diagnostics Operations, Inc. recalls Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502

Recalled October 16, 2019 · FDA recall Z-0043-2020 · Roche Diagnostics Operations

Hazard

Inaccurately Low Sample Results · FDA Class II

Units

33979 units

Sold at

AK AL AR AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY

Description

Inaccurately Low Sample Results

Product

Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 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 →