Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
FDA device recall Z-0576-06 · posted 2006-02-28 · Terminated
Recall details
- Recalling firm
- Nova Biomedical Corporation
- Reason for recall
- Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 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,
- Date initiated
- 2006-01-27
- Date posted
- 2006-02-28
- Date terminated
- 2006-10-19
- Location
- Waltham, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAT PROFILE CRITICAL CARE XPRESS ANALYZER (K020297) | Nova Biomedical Corp. | 2002-06-10 |