| Date Posted |
February 12, 2013 |
| Recall Number |
Z-0806-2013 |
| Product |
Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650.
Product Usage: 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. |
| Code Information |
Lots: 082505; 131988; 131994
|
Recalling Firm/
Manufacturer |
Remel Inc
12076 Santa Fe Trail Dr
Lenexa, Kansas 66215-3519 |
| Consumer Instructions |
Contact the recalling firm for information |
Reason for
Recall |
The firm is recalling the products due to a potential for false negative test results.
|
| 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 in Commerce |
493 of lot 082505; 529 of lot 131988; and 448 of lot 131994 |
| Distribution |
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom |
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