Device recall
Z-1502-2012: BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S…
FDA device recall · Class II · MichClone Associates, Inc.
Key facts
| Recall number (Z-number) | Z-1502-2012 |
|---|---|
| Recall event | 61384 |
| Product | BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet California, USA . For the qualitative determination of positive or negative Sickle Cell Anemia… |
| Product code | GHM |
| Recalling firm | MichClone Associates, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2012 |
| 510(k) numbers | K860812 |
| FEI number | 1831312 |
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