Drug recall
Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA recall event 83467 · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Event ID | 83467 |
|---|---|
| Recall numbers | Z-0042-2020, Z-0043-2020 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Product type | Devices |
| Products | Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502, Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Inaccurately Low Sample Results |
| Initiation date | Jul 23, 2019 |
| Report date | Oct 16, 2019 |
| Termination date | Jun 8, 2020 |
| City | Indianapolis |
| State | IN |
| Country | United States |
| FEI number | 1823260 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: