Device recall
Z-0043-2012: Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD…
FDA device recall · Class III · EMD Chemicals Inc.
Key facts
| Recall number (Z-number) | Z-0043-2012 |
|---|---|
| Recall event | 58746 |
| Product | Harleco Giemsa Stain 25 gram glass bottle, Item #228-12 Manufactured for EMD Chemicals Inc., Gibbstown, NJ 08027 1-800-222-0342 Made in India. The product is a Class I, IVD dye and chemical stain for use in Hematology. |
| Product code | KQC |
| Recalling firm | EMD Chemicals Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 13, 2011 |
| FEI number | 2244894 |
At a glance
- None 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