Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
- Company
- Nova Biomedical Corporation
- Recall Initiated
- January 27, 2006
- Posted
- February 28, 2006
- Terminated
- October 19, 2006
- Recall Number
- Z-0576-06
- Quantity
- 498 units
- Firm Location
- Waltham, MA
Reason for Recall
Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
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
Lot / Code Info
All S/N''s
Root Cause
Other
Action Taken
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.
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