Z-0043-2020 Class II Terminated
FDA device recall Z-0043-2020 was initiated by Roche Diagnostics Operations, Inc. on July 23, 2019 and is designated Class II. Reason for recall: Inaccurately Low Sample Results The recall status is terminated (terminated June 8, 2020). Affected quantity: 33979 units.
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
- 33979 units
Product Description
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 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