Device recall
Z-0192-2013: Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number…
FDA device recall · Class III · Abbott Point Of Care Inc.
Key facts
| Recall number (Z-number) | Z-0192-2013 |
|---|---|
| Recall event | 63309 |
| Product | Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot… |
| Product code | JJT |
| Recalling firm | Abbott Point Of Care Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 20, 2013 |
| 510(k) numbers | K030768 |
| FEI number | 2245578 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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