Reported Apr 5, 2017 · Terminated

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

Data Innovations, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Data Innovations, LLC · 120 Kimball Ave Ste 100 · South Burlington, VT · 05403-6837

Is this the product you have?

  • 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
Lot codes and dates
  • All drive versions were affected.
Amount recalled
657 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 21, 2019 · Data as of Sep 19, 6:04 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.