FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vactuainer SST glass and plastic tubes.
- Recall number
- Z-0052-05
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vactuainer SST glass and plastic tubes.
- Status
- Terminated
- Initiated
- 2004-08-20
- Posted
- 2004-10-28
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- There is no linkage to any particular lot of BD product.
- 510(k) numbers
- ["K023075","K921806","K960250"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28