Z-0577-06

Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413

Name: Z-0577-06 Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413
Creator: Nova Biomedical Corporation
Published: 2006-01-27
License: https://open.fda.gov/license/

Nova Biomedical Corporation / initiated 2006-01-27 / Terminated / root cause: manufacturing process

FDA source

Nova Biomedical Corporation began a recall of Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413 on 2006-01-27. The reason FDA records is "Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0577-06
Status: Terminated
Initiated: 2006-01-27
Posted: 2006-02-28
Terminated: 2006-10-19
Recalling firm: Nova Biomedical Corporation
Product: Stat Profile Critical Care PLUS (CCX) Analyzer Catalog Number: 37413
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
Root cause tag: manufacturing process
FDA root cause: Other
Action: 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.
Quantity in commerce: 408 units
Distribution: Nationwide Foreign: Canada, UAE, Taiwan, Singapore, Budapest, UK, France, Malaysia, France, Mexico, Korea, Finland, Germany, Turkey, Ireland, Italy, Austria, Australia, Netherlands, Venezuela, Japan, Greece, Thailand, Israel, Spain, China, Hong Kong, Argentina, Czech Republic, Croatia,Trinidad WI
Product codes and lots: All S/N''s

Product code CHL

K022746Class IIStat Profile Critical Care Xpress AnalyzerNova Biomedical Corp. / cleared 2002-11-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)