Device recall
Z-0680-03: CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of…
FDA device recall · Class II · Abbott Laboratories HPD/ADD
Key facts
| Recall number (Z-number) | Z-0680-03 |
|---|---|
| Recall event | 25690 |
| Product | CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL; Abbott Laboratories… |
| Product code | MOI |
| Recalling firm | Abbott Laboratories HPD/ADD |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2004 |
| 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