Recall Z-0926-2018— Abbott Point Of Care Inc.
Class II · Terminated
Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2017-09-12, terminated 2018-08-23. FDA's recall record names no specific 510(k) clearance for this event. Product: i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255). Reason: Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue..
- Recalling firm
- Abbott Point Of Care Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-12
- Terminated
- 2018-08-23
- Firm location
- Princeton, NJ, United States
Product description
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Reason for recall
Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.