Recall Z-2090-2015— BD Biosciences, Systems & Reagents

Name: FDA recall Z-2090-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-15

Class III · Terminated

Class III FDA medical device recall by BD Biosciences, Systems & Reagents, initiated 2015-06-15, terminated 2016-08-12. It names 5 FDA 510(k) clearances: K081213, K062087, K041074 and 2 more. Product: 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.. 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)..

Recalling firm: BD Biosciences, Systems & Reagents
Classification: Class III
Status: Terminated
Initiated: 2015-06-15
Terminated: 2016-08-12
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

5 on FDA's record

K081213 — BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010Bd Biosciences·cleared 2008-08-14
K062087 — BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962Bd Biosciences·cleared 2006-09-14
K041074 — BD FACSCANTO WITH BD FACSANTO SOFTWAREBd Biosciences·cleared 2004-09-17
K040725 — BD FACSCANTO SYSTEMBecton Dickinson Immunocytometry Systems·cleared 2004-09-10
K973483 — FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SETBecton Dickinson Immunocytometry Systems·cleared 1998-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.