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September 18, 2002
Company: Mysis Healthcare Systems, Inc.Date of Enforcement Report: 9/18/02 Class: II PRODUCT Mysis Commercial Laboratory. Recall # Z-1285-2. REASON Software anomaly: a result for an accesion number came across the interface as negative but should have been Do Not Result (DNR). CODE Versions 3.2.0; 3.2.2; 3.2.3, 3.3.0, 3.3.1a, 3.3.1, 3.4.0, 3.4.1b, and 3.4.1a. RECALLING FIRM/MANUFACTURER...
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Company: Mysis Healthcare Systems, IncDate of Enforcement Report: 9/18/02 Class: II PRODUCT Misys Commercial Laboratory. Recall # Z-1318-2. REASON Software anomaly. If the deformatter begins to process data prior to all patient result records or orders being extracted from the flat files, the remaining results or orders will not be extracted. This can result in...
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Company: Misys Healthcare Systems IncDate or Enforcement Report: 9/18/02 Class: II PRODUCT Misys Laboratory. Recall # Z-1281-2. REASON Software anomaly regarding cell counts. CODE Versions 5.2, 5.23 and 5.3. RECALLING FIRM/MANUFACTURER Misys Healthcare Systems Inc., Tuscon, AZ, by fax on April 23, 2002. Firm initiated recall is ongoing. VOLUME OF PRODUCT IN COMMERCE 469. DISTRIBUTION...
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