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Terminated

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

FDA Recall Z-0577-06 · Posted 2006-02-28

Recalling FirmNova Biomedical Corporation
Recall StatusTerminated
Product CodeCHL
Date Initiated2006-01-27
Date Terminated2006-10-19
Product Quantity408 units

Reason for Recall

Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022746STAT PROFILE CRITICAL CARE XPRESS ANALYZERNova Biomedical Corp. · 2002-11-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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