JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone softwar

FDA device recall Z-1680-2017 · posted 2017-02-16 · Terminated

Recall details

Recalling firm

Data Innovations, LLC

Reason for recall

Software issue resulting in the results of one patient potentially being associated with another.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

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, W

Date initiated

2014-10-23

Date posted

2017-02-16

Date terminated

2019-08-21

Location

South Burlington, VT