Device recall
Z-1501-2012: Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin…
FDA device recall · Class II · MichClone Associates, Inc.
Key facts
| Recall number (Z-number) | Z-1501-2012 |
|---|---|
| Recall event | 61384 |
| Product | Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powder; One Line Scale Two Dispensing Closures; For Invitor Diagnostics Use, Store at Room Temperature… |
| 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