BD Biosciences
Country not established
- Devices
- 10
- FDA recalls
- 4
At a glance
Market reach
- United States
- FDA recalls
What BD Biosciences makes
The company manufactures flow cytometry instruments and reagents, including the BD FACSCANTO II flow cytometer in multiple configurations (4-2-2, 4-3-3, 5-3), the BD FACSCanto flow cytometer, and associated software like BD FACSCANTO SOFTWARE. It also produces flow cytometry reagents such as the BD TRITEST CD3/CD4/CD45, BD FACSCOUNT CD4 reagents, and the BD MULTITEST 6-COLOR TBNK reagent for immune cell analysis. Additional products include the STELLAR CD61 assay for use on the IMAGN 2000 microvolume fluorimeter and calibration standards like CALIBRITE PERCP-CY5.5 beads.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Bd Facscanto Ii Flow Cytometer, Model 338960; (5-3), Model 339473; (4-2-2), Model 338962 Ref K062087
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Bd Facscanto With Bd Facsanto Software Ref K041074
Regimes: 510(k) Registry: 510(k)Bd Tritest CD3/CD4/CD45, Model 340383 Ref K071143
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Bd Facscount CD4 Reagents With Model 339010 Ref K081213
Regimes: 510(k) Registry: 510(k)Bd Multitest 6-Color Tbnk Reagent, Model 644611 Ref K090967
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 4 recalls initiated by Bd Biosciences, the earliest on 2007-04-05 and the most recent on 2007-12-21. By recorded status: 4 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 21 Dec 2007 Z-1530-2008 Unclassified (pre-2012) Terminated Values might not update in statistics views after certain functions are performed in a worksheet.
- 2 Oct 2007 Z-0526-2008 Unclassified (pre-2012) Terminated Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.
Full distribution text
- 6 Sep 2007 Z-0570-2008 Unclassified (pre-2012) Terminated Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.
Full distribution text
- 5 Apr 2007 Z-1525-2008 Unclassified (pre-2012) Terminated When data file containing one or no fluoresence parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
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Frequently asked questions
How many devices does Bd Biosciences have in the registry?
The registry currently lists 10 devices for Bd Biosciences. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bd Biosciences's devices?
Among its 10 most recently registered devices, Bd Biosciences has devices listed in FDA 510(k) (10 devices).
What risk classes do Bd Biosciences's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Bd Biosciences's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Bd Biosciences?
FDA recall records list 4 recalls initiated by Bd Biosciences, the most recent initiated on 21 Dec 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Bd Biosciences in the registry?
The most recently registered devices listed for Bd Biosciences include BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962, BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration), STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER and BD FACSCANTO WITH BD FACSANTO SOFTWARE.