Devices

Device Recall PerkinElmer Specimen Gate Screening Center software

Model / Serial
Product Code: 5002-0500; Software Versions, 1.4 and 1.6
Product Classification
Clinical Chemistry and Clinical Toxicology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK
Product Description
PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 || Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.
Manufacturer
PerkinElmer Health Sciences, Inc.
1 Event
- Recall of Device Recall PerkinElmer Specimen Gate Screening Center software

Manufacturer

PerkinElmer Health Sciences, Inc.

Manufacturer Address
PerkinElmer Health Sciences, Inc., 940 Winter St, Waltham MA 02451-1457
Manufacturer Parent Company (2017)
Perkin Elmer Inc.
Source
USFDA

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