Device Recall Autostainer Link 48, Autostainer Plus, Autostainer, and Autostainer Link Instrument

Model / Serial
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
Product Classification
Hematology and Pathology Devices
Device Class
1
Implanted device?
No
Distribution
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.
Product Description
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
Manufacturer
Dako North America Inc.
1 Event
- Recall of Device Recall Autostainer Link 48, Autostainer Plus, Autostainer, and Autostainer Link Instrument

Manufacturer

Dako North America Inc.

Manufacturer Address
Dako North America Inc., 6392 Via Real, Carpinteria CA 93013-2921
Manufacturer Parent Company (2017)
Agilent Technologies, Inc.
Source
USFDA

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