Manufacturer

BD Biosciences, Systems & Reagents

9 recalls in our database name BD Biosciences, Systems & Reagents as the manufacturing or recalling firm.

What the numbers show

Total: 9
Critical: 0
Severe: 1
Most recent: 2015-07-22

Of the 9 recalls from BD Biosciences, Systems & Reagents we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (11%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–9 of 9

LowFDA (Devices)·Z-2090-2015·2015-07-22
BD Biosciences Recalls Flow Cytometers for Missing Laser Safety Labeling
BD Biosciences is recalling 2,188 flow cytometers installed between June 2007 and September 2011 because they lack required FDA laser safety labeling.
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
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1370-2015·2015-04-08
BD FACSCalibur Instruments Recalled for Incorrect Circuit Breaker Amperage
BD Biosciences is recalling 72 BD FACSCalibur instruments because some have circuit breakers with incorrect amperage ratings, which may fail to open during over-current situations.
Product
BD FACSCalibur; Catalog Numbers 342973, 342975, 34976 In vitro Diagnostics Use.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-1375-2015·2015-04-08
BD Biosciences Recalls CD123 PE Reagent Due to Antibody Contamination
BD Biosciences is recalling one lot of CD123 PE reagent because it contains a low amount of CD4 antibody, which may result in unexpected staining patterns.
Product
CD123 (9F5) PE Catalog number 649453 Analyte Specific Reagent
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1000-2015·2015-01-28
BD Biosciences Recalls Contaminated CD8 PE In Vitro Diagnostic Reagent
BD Biosciences is recalling one lot of CD8 PE reagent contaminated with CD4 FITC, which may cause incorrect patient data.
Product
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 su
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1002-2015·2015-01-28
BD Biosciences Recalls Contaminated Anti-Lambda APC-H7 Antibody Lots
BD Biosciences is recalling two lots of Anti-Lambda APC-H7 antibody due to contamination with CD38 antibody. The product is used for in vitro flow cytometric immunophenotyping.
Product
Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for in vitro flow cytometric immunophenotyping of hematologic disorders.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2233-2014·2014-08-20
BD Multi Check CD4 Low Control Recalled for Incorrect Date Labeling
BD Biosciences is recalling 85 units of BD Multi Check CD4 Low Control due to an incorrect distribution date on the outer box label.
Product
BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-1977-2014·2014-07-09
BD FACS Canto Flow Cytometer Recalled for Non-Operational Cooling Fans
BD Biosciences is recalling 35 BD FACS Canto flow cytometers and associated fluidics carts because the laser cooling fans and internal fans are not operational.
Product
BD FACS Canto and associated Fluidics Cart Product Usage: Flow cytometer for use in In vitro Diagnostics.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1536-2014·2014-05-07
BD Biosciences Recalls Mislabeled Anti EpCAM PE Reagent Lots
BD Biosciences is recalling two lots of Anti EpCAM PE reagent because the vials contain CD9 PE antibody instead of the labeled EpCAM antibody.
Product
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.
Category
Medical Device
Distribution
7 states
LowFDA (Devices)·Z-2397-2012·2012-09-26
BD FACS 7-color Setup Beads Recalled for Incorrect CD Version
BD Biosciences is recalling 96 kits of BD FACS 7-color Setup Beads because the included CD contained the incorrect version.
Product
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, in
Category
Medical Device
Distribution
Distributed nationwide