FDA Device recall Z-1680-2017
JResultNet drivers using ASTM coding language
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of JResultNet drivers using ASTM coding language by Data Innovations, citing software issue resulting in the results of one patient potentially being associated with another.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1680-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-23 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Data Innovations |
| Distribution | US |
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
Reason
Software issue resulting in the results of one patient potentially being associated with another.
Identifiers
| code_info | All drive versions were affected. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1680-2017%22
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