Device product
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Identifier: 10758750002740
Z-2482-2020
Product summary
- Event
- Event 85762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2617 units (U.S.=1272; OUS=1344)
- Official record key
device-enforcement:Z-2482-2020
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 : J56000114- J56001879
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