—#35186

Product

BD Vactuainer SST glass and plastic tubes.

FDA product code: JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K023075, K921806, K960250
Affected lot / code info: There is no linkage to any particular lot of BD product.

Why it was recalled

"Please be aware tht this not a new recall. 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 adrenal gland function. The immunoassay results are high when

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Becton Dickinson & Company
Address: 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2004-08-20
Posted by FDA: 2004-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35186. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.