Company:Abbott Point Of Care Inc.
Date of Enforcement Report 3/14/2018
Class lI:
PRODUCT
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Recall Number Z-0946-2018
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/MANUFACTURER
Abbott Point Of Care Inc., Princeton, NJ on 8/12/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
894
DISTRIBUTION
Nationwide and Internationally
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