Z-0030-2012

Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276...

Name: Z-0030-2012 Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276...
Creator: Tcoag Us, Incorporated
Published: 2011-06-13
License: https://open.fda.gov/license/

Tcoag Us, Incorporated / initiated 2011-06-13 / Terminated / root cause: manufacturing process

FDA source

Tcoag Us, Incorporated began a recall of 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... on 2011-06-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0030-2012
Status: Terminated
Initiated: 2011-06-13
Posted: 2011-10-07
Terminated: 2012-12-11
Recalling firm: Tcoag Us, Incorporated
Product: 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.
Product code: GHH Fibrin Split Products
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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).
Quantity in commerce: 4409 Units
Distribution: Worldwide distribution: USA (nationwide) and country of: Canada.
Product codes and lots: 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

Product code GHH

K920668Class IIMinutex D-Dimer Latex TestBiopool AB / cleared 1992-10-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)