Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives
Remel Inc is recalling 50 units of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a diagnostic medical device with a potential for false negative results, which poses a risk of harm through misdiagnosis or delayed treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Remel Inc is recalling 50 units of the Remel Xpect Clostridium difficile Toxin A/B, IVD test kit (REF 24640, Lot 141764). The product 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 to aid in the diagnosis of Clostridium difficile-associated disease.
The recall was initiated because the firm identified a potential for false negative test results. This means the test may fail to detect the presence of the toxin when it is actually present in a sample.
The affected units were distributed worldwide, including the United States, Canada, and the United Kingdom. Users of the product should contact Remel Inc for further instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- Remel Inc
- Affected units
- 50
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 (1)
- Lot 141764
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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