Device evidence

device-recall:cfres:198748

ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311

Official recall number

Z-1304-2023

Evidence summary

Product code: KFF
Recall status: Open, Classified
Event initiated: February 03, 2023
Root cause: Device Design
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1304-2023