Product Wiki · Recalls · U.S. FDA — Device Enforcement

Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium… — recall Z-0806-2013

U.S. FDA — Device Enforcement · United States · 2012-08-20 · Class II

As described by U.S. FDA — Device Enforcement: 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. T

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0806-2013
Date of alert
2012-08-20
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Remel Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Reported risk: The firm is recalling the products due to a potential for false negative test results.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.