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U.S. Department of Health and Human Services

Class 2 Device Recall MedTest DX Control Reconstitution Fluid

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  Class 2 Device Recall MedTest DX Control Reconstitution Fluid see related information
Date Initiated by Firm May 15, 2015
Date Posted September 15, 2015
Recall Status1 Terminated 3 on May 23, 2016
Recall Number Z-2768-2015
Recall Event ID 71993
510(K)Number K942458  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product MedTest DX Control Reconstitution Fluid
Kit configuration: 20 x 5 ml.
Bottle: 5 ml amber glass
Cap: 18 mm white seal plug seal rubber
HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
Code Information Catalog number: HC-DIL Lot: 072414-206 Expiration date: 2016-07 
Recalling Firm/
Manufacturer		 MedtestDx, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Customer Support
734-487-8300
Manufacturer Reason
for Recall		 Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.
FDA Determined
Cause 2		 Process design
Action On 5/15/2015, MedTest DX Field Correction Notice notifications were sent to the affected customers via electronic mail and US mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to MedTest Technical Service Department at 1-800-757-5313.
Quantity in Commerce 79 kits
Distribution US Nationwide Distribution.
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 = JJY and Original Applicant = RANDOX LABORATORIES, LTD.
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