Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-0072-2020

Z-0072-2020 Class II Terminated

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

Recall Details

Product Type
Devices
Report Date
October 16, 2019
Initiation Date
August 19, 2019
Termination Date
April 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30

Product Description

BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 654587, when using BD Trucount Tubes

Reason for Recall

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.

Distribution Pattern

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

Code Information

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.

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