FDA-Device2013-02-20Class II
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.
Remel Inc
Hazard
The firm is recalling the products due to a potential for false negative test results.
Sold states
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Affected count
50 units
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2013Don't want to check this manually?
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