Device product
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Unique Identifier: 10758750031610
Z-2484-2020
Product summary
- Event
- Event 85762
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total= 353 ( U.S.= 167; OUS 186)
- Official record key
device-enforcement:Z-2484-2020
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: J76000111-J76000525
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