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U.S. Department of Health and Human Services

Class 2 Device Recall JResultNet

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  Class 2 Device Recall JResultNet see related information
Date Initiated by Firm October 23, 2014
Date Posted February 16, 2017
Recall Status1 Terminated 3 on August 21, 2019
Recall Number Z-1680-2017
Recall Event ID 76036
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product JResultNet drivers using ASTM coding language.
Calculator/data processing module, for clinical use - Stand-alone software package that provides connectivity between in-vitro diagnostic instruments and laboratory information's systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information
Code Information All drive versions were affected.  
Recalling Firm/
Manufacturer		 Data Innovations, LLC
120 Kimball Ave Ste 100
South Burlington VT 05403-6837
For Additional Information Contact Customer Service
239-931-6004
Manufacturer Reason
for Recall		 Software issue resulting in the results of one patient potentially being associated with another.
FDA Determined
Cause 2		 Software design
Action Data Innovations, LLC contacted consignees by phone, email, and post. Recall notifications were sent out on November 3, 2014. Consignees were provided instructions on how to reconfigure the drive to work around the issue. If consignees were unable to perform the work around, Customer Support is able to service the units. In order to request this service, consignees were to call 239-931-6004, 802-658-1955, or 800-332-0499. Attached to the recall notification was a response form that is to be faxed to 802-658-2782. Consignees with and without affected drives are to complete this response form. For questions regarding this recall call 239-931-6004.
Quantity in Commerce 657 units
Distribution Nationwide Distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & DC.
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.
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