Device recall
Z-0015-2014: Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United…
FDA device recall · Class II · Sekisui Diagnostics LLC
Key facts
| Recall number (Z-number) | Z-0015-2014 |
|---|---|
| Recall event | 66294 |
| Product | Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear… |
| Product code | LLH |
| Recalling firm | Sekisui Diagnostics LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 5, 2014 |
| 510(k) numbers | K102242 |
| FEI number | 1000520007 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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