Drug recall
epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2…
FDA recall event 65126 · Class II · Epocal
Key facts
| Event ID | 65126 |
|---|---|
| Recall numbers | Z-1971-2013 |
| Recalling firm | Epocal |
| Product type | Devices |
| Products | epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria at concentration values at the high-end of… |
| Initiation date | Mar 13, 2013 |
| Report date | Aug 21, 2013 |
| Termination date | Aug 31, 2016 |
| City | Ottawa |
| Country | Canada |
| FEI number | 3004959793 |
At a glance
- 1–9 Products in this recall
- 1–9 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: