Gambro Bct, Inc.
Country not established
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Gambro Bct, Inc. makes
Gambro BCT, Inc. manufactures apheresis systems and associated exchange sets designed for therapeutic plasma exchange and cell separation procedures. These include the SPECTRA OPTIA APHERESIS SYSTEM and its compatible exchange sets, as well as the COBE CENTRY TPE SYSTEM, which are used in medical treatments requiring blood component removal or replacement.
The company’s devices are classified under Class II (U) in the U.S. regulatory framework and are authorised through 510(k) and PMA pathways. These products are listed in the FDA’s regulatory databases, and the company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Cobe Centry(R) Tpe System Ref P810023
Regimes: PMA, withdrawn Registry: PMA
FDA recalls
FDA recall records list 1 recall initiated by Gambro Bct, Inc., initiated on 2007-09-18. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2007
- 18 Sep 2007 Z-0078-2008 Unclassified (pre-2012) Terminated Under specific conditions, apheresis machine could return up to 60mL of air to the patient.
Frequently asked questions
How many devices does Gambro Bct, Inc. have in the registry?
The registry currently lists 2 devices for Gambro Bct, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gambro Bct, Inc.'s devices?
Among its 2 most recently registered devices, Gambro Bct, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
Are there FDA recall records for Gambro Bct, Inc.?
FDA recall records list 1 recall initiated by Gambro Bct, Inc., the most recent initiated on 18 Sep 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 Gambro Bct, Inc. in the registry?
The most recently registered devices listed for Gambro Bct, Inc. include SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 and COBE CENTRY(R) TPE SYSTEM.