Drug recall
Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro…
FDA recall event 63680 · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Event ID | 63680 |
|---|---|
| Recall numbers | Z-0522-2013 |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Product type | Devices |
| Products | Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the… |
| Initiation date | Nov 14, 2012 |
| Report date | Dec 19, 2012 |
| Termination date | Aug 7, 2013 |
| 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: