Device product
BD FACSLyric Flow Cytometer, 2-Laser 6 Color Instrument, REF: 651165, when using BD Trucount Tubes
Z-0071-2020
Product summary
- Event
- Event 83603
- Status
- Terminated
- Classification
- Class II
- Quantity
- 36
- Official record key
device-enforcement:Z-0071-2020
Official wording
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.
Code information: BD FACSLyric Flow Cytometer serial numbers: R651165000010, R651165000023, R651165000024, R651165000025, R651165000026, R651165000027, R651165000028, R651165000029, R651165000030, R651165000031, R651165000032, R651165000033, R651165000034, R651165000035, R651165000036, R651165000037, R651165000038, R651165000039, R651165000040, R651165000041, R651165000042, R651165000043, R651165000044, R651165000045, R651165000046, R651165000048, R651165000049, R651165000050, R651165000051, R651165000052, R651165000053, R651165000054, R651165000055, R651165000057, R651165000058, R651165000060.
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
Derived failure modes
-
Unknown
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.