Misys Healthcare Systems Misys Laboratory System, versions 5.2, 5.23 and 5.3 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Misys Laboratory System, versions 5.2, 5.23 and 5.3
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Versions 5.2, 5.23 and 5.3
Products Sold
Versions 5.2, 5.23 and 5.3
Misys Healthcare Systems is recalling Misys Laboratory System, versions 5.2, 5.23 and 5.3 due to Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abn. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software anomally Results with a global flag failure that autofile without review can cause abnormal results being communicated without associated abnormal designations.
Recommended Action
Per FDA guidance
Notification was sent by fax under Product Safety Notice, PSN-03-L27 on June 10, 2003 also under PSN-03-L27 on June 13, 2003 to sites with MIM functionality.
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