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Caridianbct, Inc..

United StatesFDA applicant, unverified

Devices
2
FDA recalls
3

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Caridianbct, Inc.. makes

Caridianbct, Inc. manufactures apheresis systems designed for blood component separation, including the SPECTRA OPTIA R and SPECTRA OPTIA models. These devices are used in therapeutic apheresis procedures to collect, process, and return blood components to patients, such as plasma exchange or leukapheresis. They are intended for clinical settings where precise separation of blood elements is required.

The company’s apheresis systems fall under FDA Class II (U) devices and are listed in the FDA’s 510(k) registry. These products are regulated under the US Food and Drug Administration’s medical device authority and are intended for use within the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by Caridianbct, Inc.., the earliest on 2010-06-01 and the most recent on 2012-05-04. By recorded status: 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2012

    • 4 May 2012 Z-1683-2012 Not yet classified Terminated Defective product may result in decreased efficacy. Distribution: US Nationwide Distribution and the country of Canada. Submission number: K103090

  • 2011

    • 26 Oct 2011 Z-1504-2012 Unclassified (pre-2012) Terminated Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed. Distribution: Worldwide distribution including USA, Canada, Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Chile,…
      Full distribution text Worldwide distribution including USA, Canada, Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Netherlands, UK, Hong Kong, Hungary, India, Italy, Iran, Ireland, Israel, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Egypt, Finland, France, Germany, Japan, Malaysia, Mexico, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Romania, Russia, Spain, Saudi Arabia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, Vatican, Vietnam, and Greece.
      Submission numbers: K071079, K103090

  • 2010

    • 1 Jun 2010 Z-1541-2012 Unclassified (pre-2012) Terminated Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets. Distribution: USA Nationwide Distribution Submission number: K090003

Frequently asked questions

How many devices does Caridianbct, Inc.. have in the registry?

The registry currently lists 2 devices for Caridianbct, Inc... Devices recorded under merged duplicate company entries are counted once.

Which registries list Caridianbct, Inc..'s devices?

Among its 2 most recently registered devices, Caridianbct, Inc.. has devices listed in FDA 510(k) (2 devices).

Are there FDA recall records for Caridianbct, Inc..?

FDA recall records list 3 recalls initiated by Caridianbct, Inc.., the most recent initiated on 4 May 2012. 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 Caridianbct, Inc.. in the registry?

The most recently registered devices listed for Caridianbct, Inc.. include SPECTRA OPTIA R APHERESIS SYSTEM and SPECTRA OPTIA APHERESIS SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.