Reported Oct 16, 2019 · Terminated

BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, 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, 3-Laser 8 Color Instrument
  • REF654587, when using BD Trucount Tubes
Lot codes and dates
  • BD
  • FACSLyric Flow Cytometer serial numbers
    • R654587000008
    • R654587000009
    • R654587000010
    • R654587000011
    • R654587000024
    • R654587000026
    • R654587000027
    • R654587000028
    • R654587000029
    • R654587000030
    • R654587000031
    • R654587000032
    • R654587000033
    • R654587000034
    • R654587000035
    • R654587000036
    • R654587000037
    • R654587000038
    • R654587000039
    • R654587000040
    • R654587000041
    • R654587000042
    • R654587000043
    • R654587000044
    • R654587000045
    • R654587000046
    • R654587000047
    • R654587000048
    • R65458700020
    • Z654587P027
Amount recalled
30

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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 12, 2024 · Data as of Sep 19, 4:47 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.