Becton, Dickinson and Company, BD Biosciences: Medical Device Recall in 2019 - (Recall #: Z-0069-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes

Product Classification:

Class II

Date Initiated: August 19, 2019

Date Posted: October 16, 2019

Recall Number: Z-0069-2020

Event ID: 83603

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.

Status: Terminated

Product Quantity: 78

Code Information:

BD FACSLyric Flow Cytometer serial numbers: Z662878000003, Z662878000041, Z662878000042, Z662878000043, Z662878000044, Z662878000045, Z662878000046, Z662878000047, Z662878000049, Z662878000050, Z662878000051, Z662878000052, Z662878000053, Z662878000054, Z662878000055, Z662878000056, Z662878000057, Z662878000058, Z662878000059, Z662878000060, Z662878000061, Z662878000062, Z662878000063, Z662878000064, Z662878000065, Z662878000066, Z662878000067, Z662878000068, Z662878000069, Z662878000070, Z662878000071, Z662878000072, Z662878000073, Z662878000074, Z662878000075, Z662878000076, Z662878000077, Z662878000078, Z662878000079, Z662878000080, Z662878000081, Z662878000082, Z662878000083, Z662878000084, Z662878000085, Z662878000086, Z662878000087, Z662878000088, Z662878000089, Z662878000090, Z662878000091, Z662878000092, Z662878000093, Z662878000094, Z662878000095, Z662878000096, Z662878000097, Z662878000098, Z662878000105, Z662878000106, Z662878000107, Z662878000108, Z662878000109, Z662878000110, Z662878000111, Z662878000112, Z662878000113, Z662878000114, Z662878000115, Z662878000116, Z662878000117, Z662878000118, Z662878000119, Z662878000120, Z662878000121, Z662878000122, Z662878000123, Z662878000048.

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

Voluntary or Mandated:

Voluntary: Firm initiated