Device recall
Z-0636-05: Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 &…
FDA device recall · Class III · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0636-05 |
|---|---|
| Recall event | 31104 |
| Product | Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, Lot # 238017-02. 60 mL bottles can be part of DiaSorin Lp(a) Antibody Reagent Kits Catalog # 86084, Lot #s 1144332, 114432A,13656, 113656A, and 113656B for use in DiaSorin Antibody… |
| Product code | DFC |
| Recalling firm | Diasorin Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| 510(k) numbers | K982708 |
| FEI number | 2182595 |
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