Recall Z-0052-05 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vactuainer SST glass and plastic tubes.
| Date | Oct 28, 2004 (initiated Aug 20, 2004) |
| Status | Terminated |
| Reason | "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 | Other |
| Action | 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. |
| Quantity | There is no linkage to any particular lot of BD product |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023075 | BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE Bd Vacutainer Systems Preanalyical Solutions, Nov 25, 2002 |
| K921806 | VACUTAINER(R) BRAND SST(R) AND CAT TUBES Bd Becton Dickinson Vacutainer Systems Preanalytic, Apr 29, 1992 |
| K960250 | VACUTAINER BRAND PLUS SERUM & SST TUBES Becton Dickinson Vacutainer Systems, Mar 29, 1996 |