Reported Oct 9, 2024 · Ongoing
BD FACSDuet Premium Sample Preparation System, REF: 666340, 666339; and BD FACSDuet Sample Preparation System (Base),…
Becton, Dickinson and Company, BD Bio Sciences
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 Bio Sciences · 155 N Mccarthy Blvd · Milpitas, CA · 95035-5102
Is this the product you have?
- BD FACSDuet Premium Sample Preparation System
- REF666340, 666339; and BD FACSDuet Sample Preparation System (Base)
- REF
663128662588used with software V 1.4.1
- Intended useto prepare human specimens to be analyzed
- Lot codes and dates
- REF/UDI-DI/Serial Numbers
127 of 127 codes
666340/382906663405/9230010101923001010292300101039230010104923001010592300101079230010108923001010992300101129230010113923001011492300101159230010116923001011892300101199230010120. 666339/92300001029230000103923000010492300001059230000106923000011292300001139230000114923000011892300001209230000121923000012392300001249230000126923000012892300001309230000132923000013492300001359230000138923000014492300001459230000131923000015292300001499230000030923000010192300001089230000109923000011092300001119230000115923000011692300001179230000119923000012292300001259230000127923000012992300001369230000139923000014192300001429230000143. 663128/382906631282/92200300049220030005
- REF/UDI-DI/Serial Numbers
- Amount recalled
- 130
Where it was sold
Why it was recalled
Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.
This product could cause temporary or reversible health problems — stop using it.
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