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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:128489

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.

Official recall number

Z-2166-2014

Evidence summary

Product code
JQP
Recall status
Terminated
Event initiated
June 27, 2014
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2166-2014