Sekisui Diagnostics LLC: Medical Device Recalls in 2013

Updated on March 25, 2026.

According to to data from the FDA, there was 1 medical device recall made by Sekisui Diagnostics LLC in 2013. See the detail of the recall below.

You can see similar recalls for other firms.

Data Source: FDA.

See this for other years:

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.