Recall Z-0807-2013— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2012-08-20, terminated 2013-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product 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.. Reason: The firm is recalling the products due to a potential for false negative test results..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-20
- Terminated
- 2013-06-04
- Firm location
- Lenexa, KS, United States
Product description
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product 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.
Reason for recall
The firm is recalling the products due to a potential for false negative test results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.