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Bio-Rad Laboratories Recall 94020

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

Bio-Rad Laboratories Recall 94020 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1358-2024
Event ID94020
Event DescriptionBio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Product TypeDevices
DistributionUS Nationwide distribution in the states of PA, SD, TX, FL, MN.
Quantity33 units
Recall ReasonDue to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values.
Device Classification20240403
Device Code InfoLot # 64562656 & 64571846/ UDI: 03610521162834
Center Classification Date20240322
Recall Initiation Date20240215
Recalling FirmBio-Rad Laboratories
Initial Notification E-Mail
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