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 / number Barcodes Product 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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