Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BD Vactuainer SST glass and plastic tubes.

FDA Recall Z-0052-05 · Posted 2004-10-28

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeJKA
Date Initiated2004-08-20
Product QuantityThere is no linkage to any particular lot of BD product

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

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023075BD VACUTAINER PLUS SST SERUM SEPARATOR TUBEBd Vacutainer Systems Preanalyical Solutions · 2002-11-25K960250VACUTAINER BRAND PLUS SERUM & SST TUBESBecton Dickinson Vacutainer Systems · 1996-03-29K921806VACUTAINER(R) BRAND SST(R) AND CAT TUBESBd Becton Dickinson Vacutainer Systems Preanalytic · 1992-04-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑