FDA Device Recall Z-0030-2012: Tcoag Us, Incorporated

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0030-2012.

Recall Res Number

Z-0030-2012

Recalling Firm / Manufacturer

Tcoag Us, Incorporated

FEI Number

3005261996

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-06-13

Date Posted

2011-10-07

Date Terminated

2012-12-11

Product Code

GHH

Event Number

59957

Product Quantity

4409 Units

Product Description 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.

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.

Action Details 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).

Distribution Pattern Worldwide distribution: USA (nationwide) and country of: Canada.

Code Information / Serial Numbers 510 K number: K920668 Device listing number: D099358 Lot Numbers: Expiry Date: C040002 10 July 2012 C042002 14 Jan 2012 B218005 05 Jan 2012 B341002 03 May 2012 B144001 30 Sept 2011

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Medical Device Recall: Z-0030-2012

Recall Parameters & Description

Related Establishments / Registrations

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