Device product
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Z-0042-2020
Product summary
- Event
- Event 83467
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27676 units
- Official record key
device-enforcement:Z-0042-2020
Official wording
Reason: Inaccurately Low Sample Results
Code information: All Lots
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
Derived failure modes
-
Unknown
Inaccurately Low Sample Results