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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:179578

Beckman Coulter ACCESS Immunoassay Systems, Access Thyroglobulin Antibody II, REF A32898 (UDI: 15099590202910) for use with the Access Family of Immunoassay Systems including: Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 600i, UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, and UniCel DxC 880i systems.

Official recall number

Z-2242-2020

Evidence summary

Product code
JNL
Recall status
Terminated
Event initiated
April 30, 2019
Root cause
Other
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2242-2020

Field note

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