Device recall
Z-1244-06: CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or…
FDA device recall · Class III · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-1244-06 |
|---|---|
| Recall event | 35627 |
| Product | CA 15-3 Controls, list 9C08-10; an In Vitro diagnostic for use with the AxSYM or IMx CA 15-3 reagents, calibrators and instruments; each kit contains 2 bottles with 115D8:DF3 reactive determinants (human) prepared in TRIS buffer with protein (bovine) stabilizers to yield the following assay values… |
| Product code | MOI |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 18, 2008 |
| 510(k) numbers | K963926, K964407 |
| FEI number | 1415939 |
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