Summary
The FDA issued a Class II for Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit by Bio-Rad Laboratories. Reason: Due to incorrect calibrations and controls, their is a potential of incorrect reporting of lower %IS and molecular response values..
Details
Source
Device Recall
External ID
Z-1358-2024
Action Date
2024-04-03
Status
Ongoing
Category
device
Product Description
Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
Lot/Code Info: Lot # 64562656 & 64571846/ UDI: 03610521162834
Quantity Affected: 33 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-02-15
Company
Pleasanton, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bio-Rad Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bio-Rad Laboratories have FDA actions?
This is the only FDA action we have on record for Bio-Rad Laboratories in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1358-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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