Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: Th
FDA device recall Z-0807-2013 · posted 2013-02-12 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- The firm is recalling the products due to a potential for false negative test results.
- 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).
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- LLH
- Quantity affected
- 50 units
- Distribution
- Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
- Date initiated
- 2012-08-20
- Date posted
- 2013-02-12
- Date terminated
- 2013-06-04
- Location
- Lenexa, KS
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