Device product
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique Identifier: 10758750002979
Z-2480-2020
Product summary
- Event
- Event 85762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 779 (U.S.= 225;OUS= 554)
- Official record key
device-enforcement:Z-2480-2020
Official wording
Reason: Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Code information: Affected Serial Number Range: J36000109-J36001317
Distribution pattern: US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN
Derived failure modes
-
Unknown
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances