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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:211985

Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

Official recall number

Z-1112-2025

Evidence summary

Product code
PTF
Recall status
Open, Classified
Event initiated
January 02, 2025
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1112-2025

Field note

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