Misys Healthcare Systems Calculator/ Data Processing Module for Clinical Use. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Calculator/ Data Processing Module for Clinical Use.
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Verisons 5.2, 5.23 and 5.3
Products Sold
Verisons 5.2, 5.23 and 5.3
Misys Healthcare Systems is recalling Calculator/ Data Processing Module for Clinical Use. due to Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software Defect. When orders are modified before the Roche Cobas Integra query for a specimen, the sample ID locks.
Recommended Action
Per FDA guidance
Firm has issued notifcation to all affected customers.
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