Recall Z-0070-2020— Becton, Dickinson and Company, BD Biosciences

Name: FDA recall Z-0070-2020
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, 2-Laser 4 Color Instrument, REF: 651164, 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, 2-Laser 4 Color Instrument, REF: 651164, 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.