BD FACSLyric Flow Cytometer, 3-Laser 12 Color Instrument, REF: 663029, when using BD Trucount Tubes
Published October 16, 2019 · Recall initiated: August 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Distributor
- U.S.: CA, KS, NJ, MI, NY, PA, IL, IN, VA, WA, MD, IA, OK, RI, FL, CO, OH, TX, TN, GA, MO, MN, HI, VT, MA, NE. O.U.S. (Foreign): Germany, Italy, South Korea, Japan, United Kingdom, Poland, France, Belgium, Canada, Latvia, India, Taiwan, Ireland, Algeria, Israel, Iraq, Netherlands, Malaysia, Australia, Sweden, Colombia, Switzerland, Slovakia, Spain, Brazil, Austria, Peru, Iran, Croatia, Lithuania, Czech Republic, Saudi Arabia, Finland, Qatar, South Africa, Denmark, Turkey, Mexico, Indonesia, Ecuador, Vietnam, Singapore
- Lot
- BD FACSLyric Flow Cytometer serial numbers: R663029000001, R663029000002, R663029000003, R663029000004, R663029000005, R663029000006, R663029000007, R663029000008, R663029000010, R663029000011, R663029000012, R663029000014, R663029000015, R663029000016, R663029000017, R663029000018, R663029000021, R663029000025, R663029000031, R659180000136, R659180000160, R659180000238.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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