Recall Z-0073-2020— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-0073-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-19

Class II · Terminated

Class II FDA medical device recall by Becton, Dickinson and Company, BD Biosciences, initiated 2019-08-19, terminated 2024-04-12. It names one FDA 510(k) clearance: K170974. Product: BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, 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..

Recalling firm: Becton, Dickinson and Company, BD Biosciences
Classification: Class II
Status: Terminated
Initiated: 2019-08-19
Terminated: 2024-04-12
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K170974 — BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company·cleared 2017-07-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD FACSLyric Flow Cytometer,3-Laser 10 Color Instrument, REF: 659180 and 65918001, 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.