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Terminated

BD Vacutainer Microtainer Serum tubes (with or without gel).

FDA Recall Z-1603-05 · 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 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

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.

K002456MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992Becton Dickinson Vacutainer Systems · 2000-11-02K991702MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578Becton Dickinson Vacutainer Systems · 1999-07-28K940905MICROTAINER BRAND TUBE WITH EDTA(K2)Bd Becton Dickinson Vacutainer Systems Preanalytic · 1994-08-02K931368MICROTAINER BRAND TUBE WITH EDTABd Becton Dickinson Vacutainer Systems Preanalytic · 1993-09-28K771370ICROTAINEO BRAND TUBEBd Becton Dickinson Vacutainer Systems Preanalytic · 1977-08-03

Official Source

View FDA Recall →

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

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