Reported Mar 14, 2018 · Terminated
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI:…
Abbott Point Of Care Inc.
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: Abbott Point Of Care Inc. · 400 College Rd E · Princeton, NJ · 08540-6607
Is this the product you have?
- i-STAT DE handheld data processing module for clinical use, Software Version 2.8
- List Number08K46-01115200 (UDI: 00054749001255)
- Lot codes and dates
- All units that have been upgraded to software version 2.8
- Amount recalled
- 894
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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