Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0562-2021·Announced 2020-12-16

BD Multi-Check CD4 Low Control Recalled for Inaccurate Flow Cytometry Results

Becton, Dickinson and Company is recalling 619 vials of BD Multi-Check CD4 Low Control due to unexpected cell populations that may cause inaccurate flow cytometry results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential inaccurate test results rather than direct physical injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences, is recalling 619 vials of BD Multi-Check CD4 Low Control 2.5 mL IVD. This product is intended as a complete process control for immunophenotyping by flow cytometry. The recall affects Lot Number BM1020L and includes specific catalog numbers and UDI codes for both US and international distribution.

The recall was initiated due to recent product complaints indicating an unexpected cell population exhibiting dim CD3 expression. This issue may result in inaccurate results during the gating process of flow cytometry analysis. The affected product was distributed worldwide, including nationwide in the United States and in specific countries such as Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapore, Thailand, and Peru.

Healthcare facilities and laboratories using this product should stop using the affected vials immediately. Users should contact Becton, Dickinson and Company for instructions on how to return the product or obtain a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Category: Medical Device — In Vitro Diagnostic
Hazard: inaccurate-results
Affected units: 619

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Same manufacturer · Becton, Dickinson and Company, BD Biosciences

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