Misys Healthcare Systems Misys Laboratory with Lab Access Results application for versions 5.3 and later. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Misys Laboratory with Lab Access Results application for versions 5.3 and later.
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Versions 5.3 and later.
Products Sold
Versions 5.3 and later.
Misys Healthcare Systems is recalling Misys Laboratory with Lab Access Results application for versions 5.3 and later. due to Software anomaly may rarely allow modification of previously reported specimen results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly may rarely allow modification of previously reported specimen results.
Recommended Action
Per FDA guidance
Product Safety Notice PSN-05-01 was sent by fax on May 13, 2005 and includes a procedural work-around to avoid the defect until the firm is able to provide a software patch.
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