Medical Device Recall: Z-0015-2014

FDA Recalls dataset · Firm: Sekisui Diagnostics LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-09-16 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0015-2014.

Recall Res Number
Z-0015-2014
Recalling Firm / Manufacturer
Sekisui Diagnostics LLC
FEI Number
1000520007
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-09-16
Date Posted
2013-10-17
Date Terminated
2014-05-05
Product Code
LLH
Event Number
66294
Product Quantity
391 kits
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.
Action Details 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.
Distribution Pattern Worldwide Distribution - US (nationwide) and the countries of UK, Saudi Arabia, Dubai, Kuwait, Poland, Spain, India and Romania
Code Information / Serial Numbers 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.

Related Establishments / Registrations

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