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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:168632

ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

Official recall number

Z-0799-2019

Evidence summary

Product code
CDP
Recall status
Terminated
Event initiated
October 12, 2018
Root cause
Device Design
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-0799-2019

Field note

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