Recall Z-0043-2020 ยท LEH Radioimmunoassay, Vancomycin
Roche Diagnostics Operations, Inc.
Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
| Date | Jul 23, 2019 |
| Status | Terminated |
| Reason | Inaccurately Low Sample Results |
| Root cause | Under Investigation by firm |
| Action | 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 1-800-428-2 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152245 | ONLINE TDM Vancomycin Gen.3 Roche Diagnostics Operations (Rdo), Jan 8, 2016 |