Reported Oct 16, 2019 · Terminated
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, 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 6 Color Instrument
- REF651165, when using BD Trucount Tubes
- Lot codes and dates
- BD
- FACSLyric Flow Cytometer serial numbers
R651165000010R651165000023R651165000024R651165000025R651165000026R651165000027R651165000028R651165000029R651165000030R651165000031R651165000032R651165000033R651165000034R651165000035R651165000036R651165000037R651165000038R651165000039R651165000040R651165000041R651165000042R651165000043R651165000044R651165000045R651165000046R651165000048R651165000049R651165000050R651165000051R651165000052R651165000053R651165000054R651165000055R651165000057R651165000058R651165000060
- Amount recalled
- 36
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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