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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:210297

Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;

Official recall number

Z-0234-2025

Evidence summary

Product code
QEP
Recall status
Open, Classified
Event initiated
September 12, 2024
Root cause
Device Design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0234-2025

Field note

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