Z-1603-05

BD Vacutainer Microtainer Serum tubes (with or without gel)

Name: Z-1603-05 BD Vacutainer Microtainer Serum tubes (with or without gel)
Creator: Becton Dickinson & Company
Published: 2004-08-20
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2004-08-20 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Microtainer Serum tubes (with or without gel) on 2004-08-20. The reason FDA records is ""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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1603-05
Status: Terminated
Initiated: 2004-08-20
Posted: 2004-10-28
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Microtainer Serum tubes (with or without gel).
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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
FDA 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 in commerce: There is no linkage to any particular lot of BD product
Distribution: Worldwide distribution.
Product codes and lots: There is no linkage to any particular lot of BD product.

Product code JKA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)