Reported Feb 20, 2013 · Terminated
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage:…
Remel Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519
Is this the product you have?
- Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640
- Product UsageThe 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
- Lot codes and dates
- Lot 141764
- Amount recalled
- 50 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
The firm is recalling the products due to a potential for false negative test results.
This product could cause temporary or reversible health problems — stop using it.
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