Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives
Remel Inc is recalling specific lots of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential for false negative results in a diagnostic test for a serious infectious disease, which poses a risk of harm through misdiagnosis, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Remel Inc is recalling the Remel Xpect Clostridium difficile Toxin A/B, IVD test kits (REF 24650). The recall affects 493 units of lot 082505, 529 units of lot 131988, and 448 units of lot 131994. These products were distributed nationwide in the United States, as well as in Canada and the United Kingdom.
The firm is recalling the products due to a potential for false negative test results. The test kit is a rapid in vitro immunochromatographic test used for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens. It is intended for use as an aid in the diagnosis of Clostridium difficile-associated disease.
Healthcare providers and laboratories should check their inventory for the affected lot numbers and stop using these products. Users should contact Remel Inc for further instructions on how to return or dispose of the recalled units.
The recalled product
- Product
- 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 huma
- Manufacturer
- Remel Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: 082505
- 131988
- 131994
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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