BD Vacutainer Microtainer Serum tubes (with or without gel).
FDA device recall Z-1603-05 · 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
- 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 |
|---|---|---|
| MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 (K002456) | Becton Dickinson Vacutainer Systems | 2000-11-02 |
| MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 (K991702) | Becton Dickinson Vacutainer Systems | 1999-07-28 |
| MICROTAINER BRAND TUBE WITH EDTA(K2) (K940905) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-08-02 |
| MICROTAINER BRAND TUBE WITH EDTA (K931368) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1993-09-28 |
| ICROTAINEO BRAND TUBE (K771370) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-08-03 |