# FDA recall Z-0072-2020

> **Becton, Dickinson and Company, BD Biosciences** · Class II · device recall initiated 2019-08-19.

## Product

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

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

## Key facts

- **Recall number:** Z-0072-2020
- **Recalling firm:** Becton, Dickinson and Company, BD Biosciences
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-19
- **Report date:** 2019-10-16
- **Termination date:** 2024-04-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0072-2020

## Citation

> AI Analytics. FDA recall Z-0072-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0072-2020. Source: US FDA. Licensed CC0.

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