Recall Z-0015-2014— Sekisui Diagnostics LLC

Name: FDA recall Z-0015-2014
Creator: U.S. Food and Drug Administration
Published: 2013-09-16

Class II · Terminated

Class II FDA medical device recall by Sekisui Diagnostics LLC, initiated 2013-09-16, terminated 2014-05-05. It names one FDA 510(k) clearance: K102242. 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.. 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..

Recalling firm: Sekisui Diagnostics LLC
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Terminated: 2014-05-05
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K102242 — OSOM C. DIFFICILE TOXIN A/B TESTGenzyme Corporation·cleared 2010-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.