CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Summary
The FDA issued a Class II for CD11b APC: ASR, REF: 340936, and CE, REF: 333143 by Becton, Dickinson and Company, BD Biosciences. Reason: In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false neg.
Details
Source
Device Recall
External ID
Z-0641-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
CD11b APC: ASR, REF: 340936, and CE, REF: 333143
Lot/Code Info: REF/UDI-DI/Expiration: 340936/00382903409365/20250228; 333143/00382903331437/20250228
Quantity Affected: 464 Vials
Reason for Recall
In vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false negative results and misdiagnosis of hematological malignancy, delayed treatment, and the need for additional patient samples.
Distribution
Worldwide - US Nationwide distribution including in the states of IL, MN, FL, MI, MD, NC, NY, CA, GA, AR, KS, PA, NH, TX, OK, MA, MO, DC, AZ, IN, NJ, TN, WA, VA, CT and the countries of CA, BE, SG, HK, TW, BR, MY, IN, BO, PE, JP, MX, CL, KR, UY, AU.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-25
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 158 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-0641-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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