Recall Z-2090-2015 ยท GKZ Counter, Differential Cell
BD Biosciences, Systems & Reagents
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.
| Date | Jul 16, 2015 (initiated Jun 15, 2015) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 2188 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040725 | BD FACSCANTO SYSTEM Becton Dickinson Immunocytometry Systems, Sep 10, 2004 |
| K041074 | BD FACSCANTO WITH BD FACSANTO SOFTWARE Bd Biosciences, Sep 17, 2004 |
| K062087 | BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962 Bd Biosciences, Sep 14, 2006 |
| K081213 | BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010 Bd Biosciences, Aug 14, 2008 |
| K973483 | FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET Becton Dickinson Immunocytometry Systems, Feb 17, 1998 |