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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:182547

VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.

Official recall number

Z-2770-2020

Evidence summary

Product code
QKO
Recall status
Terminated
Event initiated
July 17, 2020
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2770-2020