Device recall
Z-1613-2018: cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692…
FDA device recall · Class II · Roche Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-1613-2018 |
|---|---|
| Recall event | 79676 |
| Product | cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate… |
| Product code | CEM |
| Recalling firm | Roche Diagnostics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 15, 2019 |
| 510(k) numbers | K032311 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database