Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
BD Flow Cytometers Recalled by BD Biosciences, Systems & Reagents Due to Instruments installed between June 2007 and September 2011...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact BD Biosciences, Systems & Reagents directly.
Affected Products
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.
Quantity: 2188 units
Why Was This Recalled?
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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BD Biosciences, Systems & Reagents
BD Biosciences, Systems & Reagents has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report