Reported Dec 16, 2020 · Terminated

BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for…

Becton, Dickinson and Company, BD Biosciences

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Becton, Dickinson and Company, BD Biosciences · 2350 Qume Dr · San Jose, CA · 95131-1812

Is this the product you have?

  • BD" Multi-Check CD4 Low Control 2.5
  • mL IVD - Product Usageintended as a complete process control for immunophenotyping by flow cytometry
Lot codes and dates

6 of 6 products

Products covered by this recall
Model / numberBarcodesProduct as published
34970300382903497034US
34970400382903497041US
34970500382903497058US BD" Multi-Check CD4 Low Control Whole Blood Control for Lymphocyte Subset Enumeration OUS Distribution Catalog Number UDI
34091400382903409143OUS only
34091500382903409150OUS only
34091600382903409167OUS only
Amount recalled
619 vials

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 11, 2022 · Data as of Sep 19, 7:00 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.