• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Vacuette 2 ml Lithium Heparin, Collection Tube

  • 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 Vacuette 2 ml Lithium Heparin, Collection Tube see related information
Date Initiated by Firm August 25, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on May 15, 2012
Recall Number Z-0623-2011
Recall Event ID 56679
510(K)Number K960857  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC.
Venous blood collection tubes.
Code Information Item number: 454237, Lot number: B061006
Recalling Firm/
Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110
For Additional Information Contact Manfred Abel
Manufacturer Reason
for Recall
Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.
FDA Determined
Cause 2
Action Greiner Bio-One instructed customers to stop distribution and to complete an attached Product Disposition form and return it via fax to Greiner Bio-One. They were further instructed to destroy any product they may have. Distributors were instructed provide a list of their customers that have received the affected item via Excel file so that they can be notified of the recall.
Quantity in Commerce 18 cases (total 21,600 pieces)
Distribution Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI.
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 = JKA and Original Applicant = GREINER AMERICA, INC.