Device product
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
Z-1261-2015
Product summary
- Event
- Event 70558
- Status
- Terminated
- Classification
- Class II
- Quantity
- 409
- Official record key
device-enforcement:Z-1261-2015
Official wording
Reason: A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.
Code information: 992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C Affected dates: 12/2013-08/2014 Each device is labeled with a unique serial number. Catalog/Model Number: - AS480 - S3800 - S3400 - AS100
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.
Derived failure modes
-
Unknown
A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.