Nova Biomedical Corporation Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
Brand
Nova Biomedical Corporation
Lot Codes / Batch Numbers
All S/N''s
Products Sold
All S/N''s
Nova Biomedical Corporation is recalling Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942 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