April 17, 2002
Company: Misys Healthcare SystemsDate of Enforcement Report: 4/17/02 Class: II PRODUCT Misys Laboratory (formerly FlexiLab) information system. Recall # Z-0803-2. REASON Software anomaly may allow patient results to be transposed against another patient header or identification. CODE Versions 5.2, 5.23, and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tuscon, AZ, by notice on March 8, 2002....
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Class: III Aeroset Chloestorol Reagent Lot 82099HW00. Firm’s list no. 7D62-01. Manufacturer: Abbott Laboratories, Inc., Sout Pasadena, CA Recalled by: Manufacturer, by letters on April 17, 2002. Firm initiated recall is ongoing Distribution: Nationwide and internatinally; 715 units were distributed Reason: Stability may be compromised over time, product currently OK Recall number: Z-1031-2
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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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