Class 2 Device Recall OSOM C. Difficile Toxin A/B Test

• Date Initiated by Firm: September 16, 2013
• Date Posted: October 17, 2013
• Recall Status: Terminated on May 05, 2014
• Recall Number: Z-0015-2014
• Recall Event ID: 66294
• 510(K)Number: K102242
• Product Classification: Reagents, clostridium difficile toxin - Product Code LLH
• 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.
• Code Information: 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.
• Recalling Firm/ Manufacturer: Sekisui Diagnostics LLC; 6659 Top Gun St; San Diego CA 92121-4113
• For Additional Information Contact: 858-777-2600
• Manufacturer 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 Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LLH and Original Applicant = GENZYME CORPORATION