Misys Healthcare Systems Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation.
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Versions 5.3 up to 5.3.2.
Products Sold
Versions 5.3 up to 5.3.2.
Misys Healthcare Systems is recalling Misys Laboratory System versions5.3 up to 5.3.2 with LabAccess Results Workstation. due to Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatmen. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software defect. When Quality Assurance failure warnings are missing from a patient's report abnormal results could be used for diagnosis or treatment.
Recommended Action
Per FDA guidance
Recall notice, PSN-03-L30, was sent by fax on 6-23-2003.. nb. Firm requests the afforementioned sentence be placed in the ER.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026