Recall Z-0807-2013 ยท LLH Reagents, Clostridium Difficile Toxin
Remel Inc
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
| Date | Feb 12, 2013 (initiated Aug 20, 2012) |
| Status | Terminated |
| Reason | The firm is recalling the products due to a potential for false negative test results. |
| Root cause | Material/Component Contamination |
| Action | Thermo Fisher sent a recall notification letter with details of the recall on August 20, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were requested to follow the instructions provided and fax back the attached "Acknowledgement & Receipt Form" to 1-877-428-1924 (toll free in the US) or 1-913-895-4190 (International). For questions contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). |
| Quantity | 50 units |
| Distribution | Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.