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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:203829

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)

Official recall number

Z-0352-2024

Evidence summary

Product code
GHH
Recall status
Open, Classified
Event initiated
October 03, 2023
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0352-2024

Field note

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