Events

Recall of OSOM C. Difficile Toxin A/B Test

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sekisui Diagnostics LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66294
  • Event Risk Class
    Class 2
  • Event Number
    Z-0015-2014
  • Event Initiated Date
    2013-09-16
  • Event Date Posted
    2013-10-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121955
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Reagents, clostridium difficile toxin - Product Code LLH
  • 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.
  • 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.

Device

OSOM C. Difficile Toxin A/B Test
  • Model / Serial
    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.
  • Product Classification
    Immunology and Microbiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania
  • 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.
  • Manufacturer
    Sekisui Diagnostics LLC

Manufacturer

Sekisui Diagnostics LLC
  • Manufacturer Address
    Sekisui Diagnostics LLC, 6659 Top Gun St, San Diego CA 92121-4113
  • Manufacturer Parent Company (2017)
    Sekisui Chemical Co. Ltd.
  • Source
    USFDA