Device recall
Z-1503-2012: Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For…
FDA device recall · Class II · MichClone Associates, Inc.
Key facts
| Recall number (Z-number) | Z-1503-2012 |
|---|---|
| Recall event | 61384 |
| Product | Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powder, Size 100 tests, Store 20-30 C, Distributed by True-Medix Diagnostic Brooklyn, NY 11228… |
| 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