Recall Z-0043-2020
Roche Diagnostics Operations, Inc. · initiated July 23, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
Codes / lots: All Lots
Reason for recall
Inaccurately Low Sample Results
FDA-determined cause: Under Investigation by firm
Action taken
1. Consignees will be provided instruction to download the updated e-barcode either from the cobas link or from the cobas e-library when available. 2. If analyzers cobas link is not connected to the Roche network, a future version of the cobas e-library CD will contain the revised e-barcodes. Download the e-barcode when available. 3. If analyzers cobas link is not connected to the Roche network and they require the updated VANC3 application e-barcode before the cobas e-library CD is available, they will be instructed to contact the Roche Support Network Customer Support Center at 1-800-428-2336 to request a Field Application Specialist to provide the VANC3 updated application. 4. Calibrate and run quality controls (QC) before running samples. 5.Complete all sections of the enclosed fax form. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
Details
- Recall number
- Z-0043-2020
- Initiated
- July 23, 2019
- Terminated
- June 8, 2020
- Product code
- LEH – Radioimmunoassay, Vancomycin
- Quantity
- 33979 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
- Recalling firm
- Roche Diagnostics Operations, Inc., Indianapolis, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0042-2020 Class II | Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c…Inaccurately Low Sample Results | 07/23/2019Terminated |