Minutex D-Dimer ; Trinity Biotech plc, Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888, Web: ww
FDA device recall Z-0030-2012 · posted 2011-10-07 · Terminated
Recall details
- Recalling firm
- Tcoag Us, Incorporated
- 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 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).
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- GHH
- Quantity affected
- 4409 Units
- Distribution
- Worldwide distribution: USA (nationwide) and country of: Canada.
- Date initiated
- 2011-06-13
- Date posted
- 2011-10-07
- Date terminated
- 2012-12-11
- Location
- Budd Lake, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MINUTEX D-DIMER LATEX TEST (K920668) | Biopool AB | 1992-10-16 |