FDA-Device2013-02-20Class II
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.
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
493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0806-2013Don't want to check this manually?
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