BD Vactuainer SST glass and plastic tubes.
FDA device recall Z-0052-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- "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
- 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE (K023075) | Bd Vacutainer Systems Preanalyical Solutions | 2002-11-25 |
| VACUTAINER BRAND PLUS SERUM & SST TUBES (K960250) | Becton Dickinson Vacutainer Systems | 1996-03-29 |
| VACUTAINER(R) BRAND SST(R) AND CAT TUBES (K921806) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-04-29 |