FDAClass IIApril 5, 2017

JResultNet drivers using ASTM coding language. recall: Software Issue

JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides…

Why was JResultNet drivers using ASTM coding language. recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All drive versions were affected.

Product
JResultNet drivers using ASTM coding language. Calculator/data processing module, for clinical use - Stand-alone software package that provides…
Recalling firm
Data Innovations, LLC
Quantity
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.
Recall date
April 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls