Reported Oct 16, 2019 · Terminated
BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 651164, when using BD Trucount Tubes
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 FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument
- REF651164, when using BD Trucount Tubes
- Lot codes and dates
- BD
- FACSLyric Flow Cytometer serial numbers
R651164000007R651164000016R651164000017R651164000019R651164000020R651164000021R651164000022R651164000023R651164000024R651164000025R651164000026R651164000027R651164000028R651164000029R651164000030R651164000031R651164000032R651164000033R651164000034R651164000035R651164000036
- Amount recalled
- 21
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
Flow cytometers, when used with specific tubes may experience excessive electronic abort counts (electronic abort count of beads exceeds 1.0% of the total processed events), which may affect the ratio of cell population events to bead events, potentially resulting in falsely high absolute counts. This may affect the following: initiation of prophylactic therapy for Opportunistic Infections (HIV patients), decisions regarding care/management (PID/immune suppressed patients), laboratory developed tests/experiments, specimen engraftment potency, and use of leucoreduced blood products for transfusion.
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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