BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
Recall
- Recall Number
- Z-2090-2015
- Event Number
- 71502
- Firm
- BD Biosciences, Systems & Reagents
- FEI Number
- 2916837
- Product Code
- GKZ
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- June 15, 2015
- Posted
- July 16, 2015
- Terminated
- August 12, 2016
- Address
- 2350 Qume Dr, San Jose, CA, 95131-1812
Description
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments. BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
BD Biosciences sent an Important Product Correction letter dated June 2015 to all affected customers. Customers were informed that a Field Service Engineer will schedule a time to perform the necessary correction. Customers with questions were instructed to contact BD Customer Support at 877-232-8995 (prompt 2). For questions regarding this recall call 408-954-6307.
Nationwide Distribution
2188 units