FDA-Device2024-04-03Class II
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Bio-Rad Laboratories
Hazard
Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Sold states
US Nationwide distribution in the states of PA, SD, TX, FL, MN.
Affected count
33 units
Manufactured in
5731 W Las Positas Blvd, N/A, Pleasanton, CA, United States
Products
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2024Don't want to check this manually?
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