Device product
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 10758750007103
Z-2481-2020
Product summary
- Event
- Event 85762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 ( U.S.= 0; OUS= 27)
- Official record key
device-enforcement:Z-2481-2020
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 : 36000192 36000396 36000430 36000431 36000446 36000468 36000504 36000517 36000577 36000580 36000585 36000631 36000647 36000366 36000267 36000386 36000404 36000420 36000562 36000614 36000575 36000589 36000480 36000582 36000687 36000492 36001042
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