Z-0806-2013Class II

Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650

Name: Z-0806-2013 Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests, REF 24650
Creator: Remel Inc
Published: 2012-08-20
License: https://open.fda.gov/license/

Remel Inc / initiated 2012-08-20 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of 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... on 2012-08-20. FDA classified it as Class II and gives the reason as "The firm is recalling the products due to a potential for false negative test results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0806-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-20
Posted: 2013-02-12
Terminated: 2013-06-04
Recalling firm: Remel Inc
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 human fecal specimens. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease.
Product code: LLH Reagents, Clostridium Difficile Toxin
Reason for recall: The firm is recalling the products due to a potential for false negative test results.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Thermo Fisher sent a recall notification letter with details of the recall on August 20, 2012 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers were requested to follow the instructions provided and fax back the attached "Acknowledgement & Receipt Form" to 1-877-428-1924 (toll free in the US) or 1-913-895-4190 (International). For questions contact the Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
Quantity in commerce: 493 of lot 082505; 529 of lot 131988; and 448 of lot 131994
Distribution: Worldwide Distribution - USA Nationwide and the countries Canada and the United Kingdom
Product codes and lots: Lots: 082505; 131988; 131994

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0806-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0806-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-12
Z-0807-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-12

Product code LLH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)