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U.S. Department of Health and Human Services

Class 2 Device Recall Minutex DDimer

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 Class 2 Device Recall Minutex DDimersee related information
Date Initiated by FirmJune 13, 2011
Date PostedOctober 07, 2011
Recall Status1 Terminated 3 on December 11, 2012
Recall NumberZ-0030-2012
Recall Event ID 59957
510(K)NumberK920668 
Product Classification Fibrin split products - Product Code GHH
ProductMinutex 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.
Code Information 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 
FEI Number 3005261996
Recalling Firm/
Manufacturer		 Tcoag Us, Incorporated
330 Waterloo Valley Rd
Budd Lake NJ 07828-1395
For Additional Information ContactMr. Thomas Lawlor
973-631-1200
Manufacturer 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 2		Nonconforming Material/Component
ActionThe 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 Commerce4409 Units
DistributionWorldwide distribution: USA (nationwide) and country of: Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GHH
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