FDA Medical Device Recalls (openFDA)
Nova Biomedical Corporation: Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
- Recall number
- Z-0576-06
- Recalling firm
- Nova Biomedical Corporation
- Product
- Stat Profile Critical Care (CCX) Analyzer Catalog Number: 35942
- Status
- Terminated
- Initiated
- 2006-01-27
- Posted
- 2006-02-28
- Terminated
- 2006-10-19
- 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
- Lot, serial or model codes
- All S/N''s
- 510(k) numbers
- ["K020297"]
- PMA numbers
- not on file
- Product code
- CHL
- Firm FEI
- 1219029
- Firm city
- Waltham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28