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.
Reported: February 20, 2013 Initiated: August 20, 2012 #Z-0806-2013
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.
Reason for Recall
The firm is recalling the products due to a potential for false negative test results.
Details
- Recalling Firm
- Remel Inc
- Units Affected
- 493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
- Distribution
- Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Remel Inc. Units affected: 493 of lot 082505; 529 of lot 131988; and 448 of lot 131994.
Why was this product recalled? ▼
The firm is recalling the products due to a potential for false negative test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0806-2013.
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