Recall Z-1603-05 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Becton Dickinson & Company
BD Vacutainer Microtainer Serum tubes (with or without gel).
| Date | Oct 28, 2004 (initiated Aug 20, 2004) |
| Status | Terminated |
| Reason | "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 |
| 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
| K002456 | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 Becton Dickinson Vacutainer Systems, Nov 2, 2000 |
| K771370 | ICROTAINEO BRAND TUBE Bd Becton Dickinson Vacutainer Systems Preanalytic, Aug 3, 1977 |
| K931368 | MICROTAINER BRAND TUBE WITH EDTA Bd Becton Dickinson Vacutainer Systems Preanalytic, Sep 28, 1993 |
| K940905 | MICROTAINER BRAND TUBE WITH EDTA(K2) Bd Becton Dickinson Vacutainer Systems Preanalytic, Aug 2, 1994 |
| K991702 | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 Becton Dickinson Vacutainer Systems, Jul 28, 1999 |