Recall Z-0576-06 ยท CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Nova Biomedical Corporation
Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
| Date | Feb 28, 2006 (initiated Jan 27, 2006) |
| Status | Terminated |
| Reason | Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs |
| 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 | 498 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020297 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER Nova Biomedical Corp., Jun 10, 2002 |