Misys Healthcare Systems Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results
Brand
Misys Healthcare Systems
Lot Codes / Batch Numbers
Version 5.2 through 5.3.2 using LabAccess Results
Products Sold
Version 5.2 through 5.3.2 using LabAccess Results
Misys Healthcare Systems is recalling Misys Laboratory System versions 5.2 through 5.3.2 using LabAccess Results due to Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software design deficiency. If the dilution factor is added to the same result twice, incorrect specimen values are reported.
Recommended Action
Per FDA guidance
Product Safety Notice, PSN-03-L04 was issued to all affected customers by fax on 07/22/2003. This included a procedural workaround to use until a software correction is made available or to use indefinitly at the user''s discretion. Completion of the recall , including release of the software fix is expected in December 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