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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:196119

cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.

Official recall number

Z-0097-2023

Evidence summary

Product code
NSU
Recall status
Terminated
Event initiated
September 08, 2022
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0097-2023