Device recall
Z-1148-2010: Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50…
FDA device recall · Class II · Abbott Molecular
Key facts
| Recall number (Z-number) | Z-1148-2010 |
|---|---|
| Recall event | 54190 |
| Product | Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Calcium Chloride - 2H2O 0.1% SDS), 5 x 9.0 mg Protease III (Proteinase K, 35 <= x <= 38 Units/mg) 2 x… |
| Product code | KEO |
| Recalling firm | Abbott Molecular |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 29, 2012 |
| FEI number | 3005248192 |
At a glance
- None 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