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Z-0066-2020 Class II Terminated

Recalled by Becton, Dickinson and Company, BD Biosciences — San Jose, CA

FDA device recall Z-0066-2020 was initiated by Becton, Dickinson and Company, BD Biosciences on August 19, 2019 and is designated Class II. 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… The recall status is terminated (terminated April 12, 2024). Affected quantity: 12.

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.

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