Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test

FDA device recall Z-0015-2014 · posted 2013-10-17 · Terminated

Recall details

Recalling firm

Sekisui Diagnostics LLC

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LLH

Quantity affected

391 kits

Distribution

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

Date initiated

2013-09-16

Date posted

2013-10-17

Date terminated

2014-05-05

Location

San Diego, CA

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