BD Vacutainer Partial Draw serum tubes (with or without gel).

FDA device recall Z-1602-05 · posted 2004-10-28 · Terminated

Recall details

Recalling firm

Becton Dickinson & Company

Reason for recall

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-0052-05). The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". There is an apparent bias in the determination of Total T3, Total T4, HBsAg, Folate BA, VB 12, BR, FSH and Cortisol hormones used to determine thyroid disease states, and a

Action taken

The firm sent out a Technical Bulletin to all consignees of the specific instrument companies involved. Mailing initial were done 9/17/2004 and a revised mailing was sent 9/23/2004. Global communication will commense 10/5/2004.

Root cause

Other

Status

Terminated

Product code

JKA

Quantity affected

There is no linkage to any particular lot of BD product

Distribution

Worldwide distribution.

Date initiated

2004-08-20

Date posted

2004-10-28

Location

Franklin Lakes, NJ