Microtainer Brand Tube With EDTA(K2)

• • Terminated Z-1603-05 FDA Unclassified (pre-2012) ·initiated 20 Aug 2004

  "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

• • Terminated Z-0447-03 FDA Unclassified (pre-2012) ·initiated 16 Oct 2002

  Insufficient amount of EDTA found within the tube causing clotting and erroneous platelet counts.

510(k) Number

K940905 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Leuco Prep

  Class I

  FDA 510(k) K854093 Active Cleared 12 Nov 1985

• Qbc System Hemoglobin

  Class II

  FDA 510(k) K874427 Active Cleared 5 Jan 1988

• Sensicare Synthetic Medical Gloves

  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

• Qbc Centrifugal Hematology Analyzer

  Class II

  FDA 510(k) K844645 Active Cleared 5 Mar 1985

• Holesterol Delta Test Assay

  Class I

  FDA 510(k) K771582 Active Cleared 13 Sep 1977

• Delta Test Triglycerides

  Class I

  FDA 510(k) K802136 Active Cleared 10 Oct 1980

See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the Microtainer Brand Tube With EDTA(K2) used for?

  The Microtainer Brand Tube With EDTA(K2) is designed for hematology and chemistry applications, specifically for capillary blood sample collection. It features a wider diameter and BD Microgard closure with an integrated collection scoop for improved mixing ability.

• Is the Microtainer Tube single-use or reusable?

  The Microtainer Brand Tube With EDTA(K2) is supplied as a single-use device, intended for one-time capillary blood sample collection to ensure diagnostic quality and prevent cross-contamination between patients.

• What sizes and models are available for the Microtainer Tube?

  The Microtainer Brand Tube With EDTA(K2) is available in various sizes to accommodate different sample collection needs. The tube is color-coded to match the array of evacuated BD Vacutainer blood collection tubes for easy identification.

• How should the Microtainer Tube be stored?

  The Microtainer Brand Tube With EDTA(K2) should be stored at room temperature to maintain its integrity and ensure proper performance during blood collection procedures.

• What is the regulatory status of the Microtainer Tube?

  The Microtainer Brand Tube With EDTA(K2) has FDA 510K clearance under product code JKA, with a decision date of 1994-08-02. It was determined to be substantially equivalent to predicate devices through the traditional clearance pathway.