Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Minutex DDimer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Minutex DDimer see related information
Date Initiated by Firm June 13, 2011
Date Posted October 07, 2011
Recall Status1 Terminated 3 on December 11, 2012
Recall Number Z-0030-2012
Recall Event ID 59957
510(K)Number K920668  
Product Classification Fibrin split products - Product Code GHH
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.
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 
Recalling Firm/
Manufacturer		 Tcoag Us, Incorporated
330 Waterloo Valley Rd
Budd Lake NJ 07828-1395
For Additional Information Contact Mr. 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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = GHH and Original Applicant = BIOPOOL AB
-
-