Recall Z-0067-2020 ยท OYE Flow Cytometric Reagents And Accessories.
Becton, Dickinson and Company, BD Biosciences
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 662876, when using BD Trucount Tubes
| Date | Aug 19, 2019 |
| Status | Terminated |
| 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 transfus |
| Root cause | Under Investigation by firm |
| Action | On 08/19/19, the recalling firm started calling and distributing Urgent Medical Device Recall notices to customers. Laboratory managers were asked to do the following: 1) Run the Abort Count Quantification Protocol. 2) Record the percentage of aborted events on the attached Customer Response Form and submit via fax, email, or online to the recalling firm regardless of the result. 3) For percent aborted events less-than 1.0 percent: your instrument is performing as expected and no further action is required once the percent aborted events has been provided to via Customer Response Form. 4) For |
| Quantity | 1 |
| 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, Australi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170974 | BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multit Becton, Dickinson and Company, Jul 3, 2017 |