FDA-Device2014-09-03Class II

BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

Becton Dickinson & Company
Hazard

BD has initiated the recall of its Vacutainer CPT Cell Preparation Tube due to poor separation, resulting in a reduced number of recovered mononuclear cells.

Sold states
US and Foreign
Affected count
296,160 tubes
Manufactured in
1 Becton Dr, N/A, Franklin Lakes, NJ, United States
Products
BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2542-2014

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