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Remel Inc recalls Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650. Product Usa
Recalled February 20, 2013 · FDA recall Z-0806-2013 · Remel
Hazard
The firm is recalling the products due to a potential for false negative test results. · FDA Class II
Units
493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
Sold at
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Description
The firm is recalling the products due to a potential for false negative test results.
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.
Manufacturer(s)
Remel Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →