Misys Healthcare Systems Mysis Laboratory version 6.1 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Mysis Laboratory version 6.1
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Version 6.1
Products Sold
Version 6.1
Misys Healthcare Systems is recalling Mysis Laboratory version 6.1 due to When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated org. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more suceptibilities on the culture will be deleted.
Recommended Action
Per FDA guidance
Firm sent Product Safety Notice PSN 05-02 on May 10, 2005 which also provides a procedural work-around and an invitation to obtain a service pack to correct the software flaw.
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