CLASS II Device recall · Reported 20 Feb 2013 · FDA Enforcement Report
Xpect Clostridium difficile Toxin A/B, IVD recalled by Remel
Remel is recalling Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, distributed nationwide in the US. The recall was initiated on 20 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0807-2013
- FDA event ID
- 63558
- Recalling firm
- Remel, Lenexa, KS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Aug 2012
- FDA classified
- 12 Feb 2013
- Reported
- 20 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Botulism
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Aug 2012 | Recall initiated by company | |
| 12 Feb 2013 | Classified by FDA | +176 days |
| 20 Feb 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is recalling the products due to a potential for false negative test results.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Questions about this recall
Is Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests recalled?
Yes. Remel recalled Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests on 20 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-0807-2013.
Why was it recalled?
The firm is recalling the products due to a potential for false negative test results.
Which lots are affected?
Lot 141764
Where was it sold?
Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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