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
|
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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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