Home / Recalls / Becton, Dickinson and Company, BD Biosciences / Z-0066-2020

Z-0066-2020 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
12

Product Description

BD FACSLyric Flow Cytometer, 2-Laser 4 Color Instrument, REF: 662875, 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: Z662875000001, Z662875000007, Z662875000008, Z662875000009, Z662875000011, Z662875000012, Z662875000013, Z662875000014, Z662875000015, Z662875000016, Z662875000017, Z662875000018.

Other recalls by Becton, Dickinson and Company, BD Biosciences

  • Z-2351-2024 Class II — BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit wi (May 8, 2024)
  • Z-0641-2024 Class II — CD11b APC: ASR, REF: 340936, and CE, REF: 333143 (October 25, 2023)
  • Z-0171-2023 Class II — BD Trucount Tubes (Cat. No. 340334), used for determining absolute counts of leu (October 3, 2022)
  • Z-0172-2023 Class II — BD Trucount Tubes (Cat. No. 663028), used for determining absolute counts of leu (October 3, 2022)
  • Z-0173-2023 Class II — BD Multitest 6-Color TBNK with optional BD Trucount Tubes (Cat. No. 662995), for (October 3, 2022)
  • Z-1215-2022 Class II — BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-K (March 25, 2022)
  • Z-1214-2022 Class II — BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti- (March 25, 2022)
  • Z-2333-2021 Class II — BD" Mouse IgG2a Isotype Control APC X39 ASR (July 22, 2021)
  • Z-0562-2021 Class II — BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a comple (October 5, 2020)
  • Z-1971-2020 Class II — Analyte specific reagent. REF/UDI: 641408/641408-4012-1-1 (US); 641417/641417-11 (March 31, 2020)