Device product
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
Z-0985-2014
Product summary
- Event
- Event 66958
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0985-2014
Official wording
Reason: The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.
Code information: Part Number A30260. Serial Numbers 900781.
Distribution pattern: Worldwide Distribution: US Distribution in South Dakota and the countries of Germany, Lebanon, and China.
Derived failure modes
-
Unknown
The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured with non-conforming bushings. Non-conforming bushings have a remote probability of generating incorrect results.