Becton, Dickinson and Company, BD Biosciences: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

Is my product affected?

BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

• UPC 00382903497034
• UPC 00382903497041
• UPC 00382903497058
• UPC 00382903409143
• UPC 00382903409150
• UPC 00382903409167

Check against the official notice below — it lists the full affected range.

What happened

Becton, Dickinson and Company is recalling BD Multi-Check CD4 Low Control 2.5 mL, a product designed to serve as a complete process control for immunophenotyping by flow cytometry. The recall was initiated due to customer complaints indicating an unexpected cell population with dim CD3 expression in the product, which may lead to inaccurate results during gating procedures used in flow cytometry analysis.

The affected product was distributed worldwide, including across numerous U.S. states and 13 international countries. A total of 619 vials are involved in the recall, spanning multiple lot numbers and catalog numbers for both U.S. and international distribution. According to the recall record, no specific remedy or consumer action is specified.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

Details from the source

Reason for recall: Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The countries of Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapore, Thailand, and Peru. Quantity: 619 vials Lot/code info: Lot Number: BM1020L BD Multi-Check CD4 Low Control (US Distribution) Catalog Number UDI 349703 00382903497034 US 349704 00382903497041 US 349705 00382903497058 US BD" Multi-Check CD4 Low Control Whole Blood Control for Lymphocyte Subset Enumeration OUS Distribution Catalog Number UDI 340914 00382903409143 OUS only 340915 00382903409150 OUS only 340916 00382903409167 OUS only

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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