Recall Z-0806-2013
Remel Inc · initiated August 20, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lots: 082505; 131988; 131994
Reason for recall
The firm is recalling the products due to a potential for false negative test results.
FDA-determined cause: Material/Component Contamination
Action taken
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).
Details
- Recall number
- Z-0806-2013
- Initiated
- August 20, 2012
- Posted by FDA
- February 12, 2013
- Terminated
- June 4, 2013
- Product code
- LLH – Reagents, Clostridium Difficile Toxin
- Quantity
- 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
- Recalling firm
- Remel Inc, Lenexa, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0807-2013 Class II | Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B…The firm is recalling the products due to a potential for false negative test results. | 08/20/2012Terminated |