Device recall
Z-0860-06: ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests)…
FDA device recall · Class III · Abbott Laboratories MPG
Key facts
| Recall number (Z-number) | Z-0860-06 |
|---|---|
| Recall event | 34923 |
| Product | ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3; Abbott Laboratories, Abbott Park, IL 60064 |
| Product code | LIG |
| Recalling firm | Abbott Laboratories MPG |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 31, 2006 |
| 510(k) numbers | K984108 |
| FEI number | 1415939 |
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