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FDAFDA · Food and drugs·Recall number Z-0042-2020

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

Published October 16, 2019 · Recall initiated: July 23, 2019

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Inaccurately Low Sample Results

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Roche Diagnostics Operations, Inc.
Distributor
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
Lot
All Lots
Risk classification
Class II
Area (FDA)
device
Country
United States

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