Recall Z-1358-2024— Bio-Rad Laboratories

Name: FDA recall Z-1358-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-15

Class II · Ongoing

Class II FDA medical device recall by Bio-Rad Laboratories, initiated 2024-02-15. It names one FDA 510(k) clearance: K181661. Product: Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit. Reason: Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values..

Recalling firm: Bio-Rad Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2024-02-15
Firm location: Pleasanton, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K181661 — QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc.·cleared 2019-02-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.