Device 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.
Z-0806-2013
Product summary
- Firm
- Remel Inc
- Event
- Event 63558
- Status
- Terminated
- Classification
- Class II
- Quantity
- 493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
- Official record key
device-enforcement:Z-0806-2013
Official wording
Reason: The firm is recalling the products due to a potential for false negative test results.
Code information: Lots: 082505; 131988; 131994
Distribution pattern: Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Derived failure modes
-
Unknown
The firm is recalling the products due to a potential for false negative test results.