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U.S. Department of Health and Human Services

Class 2 Device Recall Vacuette 4ml FX Sodium Fluoride / Potassium Oxalate tube

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  Class 2 Device Recall Vacuette 4ml FX Sodium Fluoride / Potassium Oxalate tube see related information
Date Initiated by Firm April 26, 2016
Create Date June 07, 2016
Recall Status1 Terminated 3 on August 22, 2016
Recall Number Z-1923-2016
Recall Event ID 74002
510(K)Number K971239  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297
VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
Code Information Lot A151137L
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information Contact Manfred Abel
704-261-7823
Manufacturer Reason
for Recall		 The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.
FDA Determined
Cause 2		 Process control
Action Greiner Bio-One North America, Inc. sent an Urgent Product Recall letter dated April 26, 2016, to all affected consignees. The letter requested that they stop distribution of the product and to provide Greiner with a list of their sub-accounts. The letter included a Product Disposition/Site Confirmation form which is to be returned to Greiner Bio-one. Consignees with questions were instructed to call 800-515-8112. For questions regarding this recall call 704-261-7823.
Quantity in Commerce 250,800 pieces (209 cases)
Distribution Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
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.
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