Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888, Web: www.trinitybiotech.com Minutex D-Dimer is a latex agglutination test for semiquantitative determination of fibrin D-Dimer.
FDA Recall Z-0030-2012 · Posted 2011-10-07
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Recalling FirmTcoag Us, Incorporated
Recall StatusTerminated
Product CodeGHH
Date Initiated2011-06-13
Date Terminated2012-12-11
Product Quantity4409 Units
Reason for Recall
There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Dimer.
Firm Action
The firm,Tcoag US, Incorporated, sent an "Urgent Device Recall" letter dated June 13, 2011 via UPS to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine the products subject to recall; complete and return the attached Product Recall Notification Response Form by June 22, 2011 via fax at 973-775-3085; scrap the products consistent with their laboratory policy and if they have further distributed these products, notify their customers to quarantine and scrap the recalled product.
For questions or technical assistance, please call the Tcoag hotline at 1-888-291-0415, option 2 (7.30 am to 6.00 pm Eastern Time).
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution: USA (nationwide) and country of: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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