Misys Healthcare Systems Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Version 5.3 and up to 5.3.2 with Anatomic Pathology Module.
Products Sold
Version 5.3 and up to 5.3.2 with Anatomic Pathology Module.
Misys Healthcare Systems is recalling Misys Laboratory System versions 5.3 up to 5.3.2 with Anatomic Pathology Module due to Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomaly allows patient reports to contain incomplete data used for diagnosis or treatment.
Recommended Action
Per FDA guidance
The firm sent a fax of Product Safety Notice PSN-03-L28 to customers on June 16, 2003 which contained a procedural workaround. Once the corrective software is released a second notice will be made to affected customers. Proposed recall completion date is 9/15/2003.
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