Device recall
Z-0470-06: Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the…
FDA device recall · Class III · Chembio Diagnostic System Inc
Key facts
| Recall number (Z-number) | Z-0470-06 |
|---|---|
| Recall event | 34263 |
| Product | Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate… |
| Product code | GHM |
| Recalling firm | Chembio Diagnostic System Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 30, 2006 |
| 510(k) numbers | K841272 |
| FEI number | 2431980 |
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