FDA recall Z-1358-2024

Bio-Rad Laboratories · Class II · device

Product

Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit

Reason for recall

Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.

Distribution

US Nationwide distribution in the states of PA, SD, TX, FL, MN.

Key facts

Status
Ongoing
Initiation date
2024-02-15
Report date
2024-04-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pleasanton, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1358-2024