Sekisui Diagnostics LLC: 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.

Recall number

Z-0015-2014

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.

Status

Terminated

Initiated

2013-09-16

Posted

2013-10-17

Terminated

2014-05-05

Reason

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.

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

391 kits

Distribution

Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania

Lot, serial or model codes

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.

510(k) numbers

["K102242"]

PMA numbers

not on file

Product code

LLH

Firm FEI

1000520007

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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