BD Biosciences, Systems & Reagents

9 recalls •

• Categories: Diagnostic Equipment, Other Medical Devices

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.

Class I - Dangerous

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).

Jun 15, 2015 Diagnostic Equipment Nationwide View Details →

CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent

Class I - Dangerous

One lot of BD CD123 PE (ASR) has been determined to contain a low amount of CD4 antibody and may result in an unexpected staining pattern.

Mar 23, 2015 Other Medical Devices View Details →

BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.

Class I - Dangerous

The circuit breakers on some BD FACSCalibur instruments may have the incorrect rated amperage (20 amps instead of 2 amps) causing the circuit breaker to fail to open in an over-current situation.

Mar 6, 2015 Diagnostic Equipment View Details →

CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

Class I - Dangerous

One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.

Dec 19, 2014 Diagnostic Equipment Nationwide View Details →

Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.

Class I - Dangerous

Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.

Dec 19, 2014 Other Medical Devices Nationwide View Details →

BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.

Class I - Dangerous

The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02

Jul 18, 2014 Other Medical Devices View Details →

BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.

Class I - Dangerous

Laser cooling fans and internal fan of the associated fluidics cart are not operational.

Jun 6, 2014 Diagnostic Equipment Nationwide View Details →

Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified as a 40 -kilodalton (kd) protein in Western Blotting.

Class I - Dangerous

Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.

Apr 4, 2014 Other Medical Devices View Details →

BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagnostic use on BD FACSCanto or BD FACSCanto II systems. The beads are run with BD FACSCanto clinical software. This system provides application specific setup, including automated compensation and cytometer quality control (QC) with minimal user intervention.

Class I - Dangerous

Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.

Jun 29, 2012 Diagnostic Equipment Nationwide View Details →