Device recall
Z-2558-2011: OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples…
FDA device recall · Class II · OPTI Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2558-2011 |
|---|---|
| Recall event | 58272 |
| Product | OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium potassium, chloride, ionized calcium and pH in samples of whole blood, serum and… |
| Product code | CGZ |
| Recalling firm | OPTI Medical Systems, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2011 |
| 510(k) numbers | K052027 |
| FEI number | 3004102403 |
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