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U.S. Department of Health and Human Services

Class 3 Device Recall Captia (TM) Syphilis IgM Capture

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 Class 3 Device Recall Captia (TM) Syphilis IgM Capturesee related information
Date Initiated by FirmNovember 17, 2014
Date PostedDecember 16, 2014
Recall Status1 Terminated 3 on May 24, 2016
Recall NumberZ-0819-2015
Recall Event ID 69827
510(K)NumberK904524 
Product Classification Enzyme linked immunoabsorption assay, treponema pallidum - Product Code LIP
ProductTrinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in human serum.
Code Information Lot 033, expiry date 30 November 2014
Recalling Firm/
Manufacturer		 Clark Laboratories, Inc. (dba,Trinity Biotech USA)
2823 Girts Rd
Jamestown NY 14701-9666
For Additional Information ContactMs. Bonnie B. DeJoy
716-483-3851 Ext. 1030
Manufacturer Reason
for Recall		Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.
FDA Determined
Cause 2		Under Investigation by firm
ActionRecall notification letters were sent by e-mail to 2 US customers on 11/17/2014 and 11/19/2014. The remaining US customers were sent the letter by FedEx on 11/19/2014. Customers are instructed to discontinue use of any remaining inventory (discard on site if any remain) and provide date of last use (run) and if they obtained valid or invalid runs. Additionally, Trinity is in the process of sending the recall letters to the required EU Regulatory Authorities and the 3 foreign distributors.
Quantity in CommerceDomestic: 9 kits; Foreign: 26 kits
DistributionNew York, Florida, Utah, and California plus foreign distribution to Spain and France
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LIP
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