FDA Device recall Z-0068-2020
BD FACSLyric Flow Cytometer, 3-Laser 8 Color Instrument, REF: 662877, 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 8 Color Instrument, REF: 662877, 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-0068-2020 |
| 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 8 Color Instrument, REF: 662877, 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: Z662877000001, Z662877000002, Z662877000003, Z662877000004, Z662877000…BD FACSLyric Flow Cytometer serial numbers: Z662877000001, Z662877000002, Z662877000003, Z662877000004, Z662877000005, Z662877000006, Z662877000007, Z662877000008. |
|---|
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-0068-2020%22
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