Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
Reported: October 16, 2019 Initiated: July 23, 2019 #Z-0042-2020
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
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 27676 units
- Distribution
- 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
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 27676 units.
Why was this product recalled? ▼
Inaccurately Low Sample Results
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2019. Severity: Moderate. Recall number: Z-0042-2020.
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