Device recall
Z-1070-2018: RaPET RF Latex Reagent used as a component in the following kits: RaPET RF…
FDA device recall · Class II · Stanbio Laboratory, LP
Key facts
| Recall number (Z-number) | Z-1070-2018 |
|---|---|
| Recall event | 79245 |
| Product | RaPET RF Latex Reagent used as a component in the following kits: RaPET RF (1155-100, Control# 173201 expiry 2019-04-30) RF Latex (1156-001, Control# 172224 expiry 2019-12-31) RF Latex (1155L-100B, Control # 172701 expiry 2019-09-30 and Control # 173262 expiry 2019-12-31) Product Usage: RaPET RF is… |
| Product code | DHR |
| Recalling firm | Stanbio Laboratory, LP |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 27, 2018 |
| 510(k) numbers | K974370 |
| FEI number | 1616487 |
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