Z-0015-2014Class II

Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for...

Name: Z-0015-2014 Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for...
Creator: Sekisui Diagnostics LLC
Published: 2013-09-16
License: https://open.fda.gov/license/

Sekisui Diagnostics, LLC / initiated 2013-09-16 / Terminated

FDA source

Sekisui Diagnostics LLC began a recall of Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro... on 2013-09-16. FDA classified it as Class II and gives the reason as "Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0015-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Posted: 2013-10-17
Terminated: 2014-05-05
Recalling firm: Sekisui Diagnostics, LLC
Product: Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD.
Product code: LLH Reagents, Clostridium Difficile Toxin
Reason for recall: Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results.
FDA root cause: Other
Action: Sekisui Diagnostic sent an Customer Recall Notification letter dated September 16, 2013, via email and/or FedEx. The letter identified the product the problem and the action needed to be taken by the customer. The customer notification letter informs the customers that Sekisui Diagnostics has issued a Product Correction for certain lots of the OSOM C. difficile Toxin A/B Test Kit (P/N 173). The customer notification lists the reason for recall, instructions to the customer, product description, required actions, and contact information. Customer Notification Letter lists the specific lot numbers being recalled for that catalog number. For each of these two catalog numbers, there is one letter directed to a distributor and one letter directed to an end user. Customer letters will be sent by email and/or FedEx. The letters have REQUIRED ACTIONS outlined in a box. If no response is received within 30 days, there will be directed follow-up communication. For further questions please call ( 858) 777-2600.
Quantity in commerce: 391 kits
Distribution: Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania
Product codes and lots: The following are part numbers and lot number combinations. PN:173E, LN:121272. PN:173, LN:121273. PN:173, LN:121273A. PN:173E, LN:131155. PN:173, LN:131156.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0015-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0015-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-23	2013-10-17

Product code LLH

K102242Class IOsom C. Difficile Toxin A/b TestGenzyme Corporation / cleared 2010-12-21

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)