Device Recall Remel X/pect Clostridium Difficile Toxin A/B (20 tests)

  • Model / Serial
    Lots: 082505; 131988; 131994
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Manufacturer Parent Company (2017)
  • Source
    USFDA