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BD Biosciences, Systems & Reagents Recalls
9 recalls on record · September 26, 2012 to July 22, 2015 · Medical Devices
Recalls by year
12
14
15
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 22, 2015Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,B
Hazard: 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).
April 8, 2015Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Hazard: 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.
April 8, 2015Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Hazard: 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.
January 28, 2015Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping
Hazard: Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody.
January 28, 2015Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reag
Hazard: One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and incorrect patient data.
August 20, 2014Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by fl
Hazard: The outer box label contains the incorrect distribution date: Box states 2017-09-02 ; should be 2014-09-02
July 9, 2014Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Hazard: Laser cooling fans and internal fan of the associated fluidics cart are not operational.
May 7, 2014Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has
Hazard: Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present in the vial is CD9 PE.
September 26, 2012Medical DevicesFDA
BD Biosciences, Systems & Reagents recalls BD FACS 7-color Setup beads BD Biosciences, San Jose, CA 95131. BD FACS 7 color Setup Beads are for in vitro diagn
Hazard: Incorrect version of the CD was included with BD FACS 7 Color Setup Beads.