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.
FDA Recall Z-2090-2015 · Posted 2015-07-16
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Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeGKZ
Date Initiated2015-06-15
Date Terminated2016-08-12
Product Quantity2188 units
Reason for Recall
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).
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K081213BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010Bd Biosciences · 2008-08-14K062087BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962Bd Biosciences · 2006-09-14K041074BD FACSCANTO WITH BD FACSANTO SOFTWAREBd Biosciences · 2004-09-17K040725BD FACSCANTO SYSTEMBecton Dickinson Immunocytometry Systems · 2004-09-10K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETBecton Dickinson Immunocytometry Systems · 1998-02-17
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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