Device recall
Z-1825-2013: Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL…
FDA device recall · Class II · Steritec Products Mfc. Co., Inc.
Key facts
| Recall number (Z-number) | Z-1825-2013 |
|---|---|
| Recall event | 65473 |
| Product | Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at 135… |
| Product code | FRC |
| Recalling firm | Steritec Products Mfc. Co., Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 19, 2013 |
| 510(k) numbers | K111150 |
| FEI number | 1000125215 |
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