Device recall
Z-0042-2012: IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz…
FDA device recall · Class II · Exalenz Bioscience Ltd
Key facts
| Recall number (Z-number) | Z-0042-2012 |
|---|---|
| Recall event | 59891 |
| Product | IDkit:HP" Breath Test for Detection of H. pylori, Manufactured by: Exalenz Bioscience Ltd 4 Ha' maayan St. Modiin, Israel 71700, Distributed by: Exalenz Bioscience Inc., 1313 N. Market St., Sute 5100, Wilmington, DE 19808 USA Product Usage: The IDkit:HP Two Test System is intended for use in the… |
| Product code | MSQ |
| Recalling firm | Exalenz Bioscience Ltd |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 6, 2012 |
| FEI number | 3005772418 |
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