Recall Z-0030-2012
Tcoag Us, Incorporated · initiated June 13, 2011
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.
Codes / 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
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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).
Details
- Recall number
- Z-0030-2012
- Initiated
- June 13, 2011
- Posted by FDA
- October 7, 2011
- Terminated
- December 11, 2012
- Product code
- GHH – Fibrin Split Products
- Quantity
- 4409 Units
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Recalling firm
- Tcoag Us, Incorporated, Budd Lake, NJ