Home / Recalls / Roche Diagnostics Operations, Inc. / Z-0042-2020

Z-0042-2020 Class II Terminated

Recalled by Roche Diagnostics Operations, Inc. — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
October 16, 2019
Initiation Date
July 23, 2019
Termination Date
June 8, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27676 units

Product Description

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

Reason for Recall

Inaccurately Low Sample Results

Distribution Pattern

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

Code Information

All Lots

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