Devices

Device Recall BD FACS Sample Prep Assistant II

Model / Serial
Serial Numbers: T0246 to T0290 (except for T0274,T0275,T0277 and T0279)
Product Classification
Hematology and Pathology Devices
Distribution
Worldwide Distribution --- USA including states of: NJ, IL, TX, PA, NY, MN, and AZ, and countries of Australia, Belgium, Hong Kong, Trinidad and Tobago. Australia, Belgium, Hong Kong, Trinidad and Tobago.
Product Description
BD FACS Sample Prep Assistant II, Part Number: 337170; || Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131
Manufacturer
BD Biosciences
1 Event
- Recall of Device Recall BD FACS Sample Prep Assistant II

Manufacturer

BD Biosciences

Manufacturer Address
BD Biosciences, 2350 Qume Dr, San Jose CA 95131-1807
Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
USFDA

2 devices with a similar name

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Device Recall BD FACS Sample Prep Assistant II (SPA II)

Model / Serial
Sample Probe Catalog Numbers 337170, 333494, 333485, 339118, 647768, 647769, and lot numbers , 92035 and 92036.
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.
Product Description
BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis
Manufacturer
BD Biosciences, Systems & Reagents

Device Recall BD FACS Sample Prep Assistant III (BD SPA III)

Model / Serial
Model/Catalog No. 647205. Manufacturing Lot/Serial # X0039; Sample Probe Catalog Numbers: 333494, 333485, 339118, 647768, and 647769/Lot Nos. 92035 and 92036
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.
Product Description
BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. || The intended use for the BD FACS Sample Prep Assistant is to prepare human whole blood samples for flow cytometry analysis.
Manufacturer
BD Biosciences, Systems & Reagents

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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