BD" Mouse IgG2a Isotype Control APC X39 ASR
Summary
The FDA issued a Class II for BD" Mouse IgG2a Isotype Control APC X39 ASR by Becton, Dickinson and Company, BD Biosciences. Reason: Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error.
Details
Source
Device Recall
External ID
Z-2333-2021
Action Date
2021-09-01
Status
Terminated
Category
device
Product Description
BD" Mouse IgG2a Isotype Control APC X39 ASR
Lot/Code Info: Catalog Number: 340757 UDI: 00382903407576 Lot Number: 0253432
Quantity Affected: 23 reagents
Reason for Recall
Complaints have been received for performance issues related to high background and staining. this issues is related to a manufacturing process error that can potentially cause a false positive staining due to contamination with another antibody.
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of CT, FL, KY, NY, and PA. The country of Taiwan.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-22
Company
San Jose, 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 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Becton, Dickinson and Company, BD Biosciences has 8 FDA actions in our database, including 8 recalls.
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 (Becton, Dickinson and Company, BD Biosciences) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Becton, Dickinson and Company, BD Biosciences have FDA actions?
Becton, Dickinson and Company, BD Biosciences has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2333-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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