FDAFDA · Food and drugs·Recall number Z-0806-2013
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.
Published February 20, 2013 · Recall initiated: August 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm is recalling the products due to a potential for false negative test results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
- Lot
- Lots: 082505; 131988; 131994
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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