Recall Z-0030-2012 ยท GHH Fibrin Split Products
Tcoag Us, Incorporated
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.
| Date | Oct 7, 2011 (initiated Jun 13, 2011) |
| Status | Terminated |
| Reason | 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 | 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. |
| Quantity | 4409 Units |
| Distribution | Worldwide distribution: USA (nationwide) and country of: Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920668 | MINUTEX D-DIMER LATEX TEST Biopool AB, Oct 16, 1992 |