FDA Device recall Z-0807-2013
Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640
- FDA Device
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640 by Remel, citing the firm is recalling the products due to a potential for false negative test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0807-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-20 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | US |
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 specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
Reason
The firm is recalling the products due to a potential for false negative test results.
Identifiers
| code_info | Lot 141764 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0807-2013%22
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