Nova Biomedical Corporation CCX Operating Software , Version 4.08 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CCX Operating Software , Version 4.08
Brand
Nova Biomedical Corporation
Lot Codes / Batch Numbers
Version 4.08
Products Sold
Version 4.08
Nova Biomedical Corporation is recalling CCX Operating Software , Version 4.08 due to Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Recommended Action
Per FDA guidance
Nova Biomedical Issued on 1/27/2006 an Advisory Notice to Stat Profile CCX Customers to report the malfunction and request the Good Laboratory Practices (GLP) be used and review be made to assure the calibration status and QC is being performed. A new software version is scheduled to be released to correct the error.
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