Company: Misys Healthcare Systems.Date of Enforcement Report: 9/29/2005 Class:II PRODUCT Misys Laboratory version 6.1 – Microbiology Module, Recall # Z-0088-06 REASON Software problem when the user has indicated to enter a coded comment instead of using the defined keyboard, then enters 100,000 the system will file the number 100 instead of number 100,000. CODE All...Read More

/docs/GlucoseMeterFDASafetyAlert102605.pdfRead More

Company: Baxter Healthcare Corp.Date of Enforcement Report: 10/26/2005 Class:II PRODUCT Baxter’s Patient Care System (BPCS) software, Pharmacy Management – Inpatient – product code 2M5013 and Point of Care – product code 2M5014; made in Canada, Recall # Z-0061-06 REASON If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached...Read More

Company: Abbott Diabetes Care, Inc..Date of Enforcement Report: 6/7/05 Class:I PRODUCT Abbott Diabetes Care, Inc. Blood Glucose Meters REASON The recalled Abbott blood glucose meters can inadvertently switch the glucose readings from mg/dL, the U.S. standard to mmol/L, the foreign standard. The unit of measure could change in the course of setting the time and...Read More