Recall Z-0015-2014 ยท LLH Reagents, Clostridium Difficile Toxin
Sekisui Diagnostics LLC
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 in the test line region indicating a positive result. A red control line must appear for the results
| Date | Oct 17, 2013 (initiated Sep 16, 2013) |
| Status | Terminated |
| Reason | 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 results. |
| Root cause | Other |
| Action | Sekisui Diagnostic sent an Customer Recall Notification letter dated September 16, 2013, via email and/or FedEx. The letter identified the product the problem and the action needed to be taken by the customer. The customer notification letter informs the customers that Sekisui Diagnostics has issued a Product Correction for certain lots of the OSOM C. difficile Toxin A/B Test Kit (P/N 173). The customer notification lists the reason for recall, instructions to the customer, product description, required actions, and contact information. Customer Notification Letter lists the specific lot nu |
| Quantity | 391 kits |
| Distribution | Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102242 | OSOM C. DIFFICILE TOXIN A/B TEST Genzyme Corporation, Dec 21, 2010 |