FDA Device recall Z-0069-2020

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

FDA Device
Class II
terminated
Published 2019-10-16

On 2019-10-16 the FDA classified a Class II recall of BD FACSLyric Flow Cytometer, 3-Laser 10 Color Instrument, REF: 662878, and 66287808 when using BD Trucount Tubes by Becton Dickinson And Bd Biosciences, citing 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….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0069-2020
Classification	Class II
Status	terminated
Initiated	2019-08-19
Published	2019-10-16
Last updated	2026-09-13 11:55 UTC
Company	Becton Dickinson And Bd Biosciences
Distribution	CA, CO, FL, GA, HI, IA, IL, IN, KS, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, PA, RI, TN, TX, VA, VT, WA

Product

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

Reason

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.

Identifiers

code_info	BD FACSLyric Flow Cytometer serial numbers: Z662878000003, Z662878000041, Z662878000042, Z662878000043, Z662878000… 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, Z6628780001

code_info

BD FACSLyric Flow Cytometer serial numbers: Z662878000003, Z662878000041, Z662878000042, Z662878000043, Z662878000…

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, Z6628780001

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0069-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.