Device product
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Z-0309-2018
Product summary
- Event
- Event 78613
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0309-2018
Official wording
Reason: Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Code information: Serial/Lot Numbers: 507114, 503299 and 508111
Distribution pattern: Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
Derived failure modes
-
Unknown
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.