Drug recall
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for…
FDA recall event 66294 · Class II · Sekisui Diagnostics LLC
Key facts
| Event ID | 66294 |
|---|---|
| Recall numbers | Z-0015-2014 |
| Recalling firm | Sekisui Diagnostics LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative… |
| Initiation date | Sep 16, 2013 |
| Report date | Oct 23, 2013 |
| Termination date | May 5, 2014 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 1000520007 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: