Microtainer Brand Tube with EDTA

• • Terminated Z-1967-2019 FDA Class II ·initiated 3 Jun 2019

  The products have been confirmed to have reduced or no additive within the tube reservoir. The tubes may develop visible clots within the tube samples or micro clots that are not easily detected during visual inspection of the tubes. A clotted sample may lead to recollection of samples or, retesting of patients, resulting in delayed reporting of test results and patient treatment.

• • 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

510(k) Number

K931368 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K915478 Active Cleared 27 Jan 1992

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  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 used for?

  The Microtainer Brand Tube with EDTA is specifically designed for preanalytic sample preparation in clinical laboratories. It contains Ethylenediaminetetraacetic acid (EDTA) as an anticoagulant to prevent blood clotting, ensuring accurate and stable sample integrity for diagnostic testing in hematology and chemistry applications. Its compact size makes it ideal for microcollection scenarios where precise sample volumes are required.

• How is the Microtainer Brand Tube with EDTA supplied and intended for use?

  The Microtainer Brand Tube with EDTA is supplied as a single-use, sterile device, intended exclusively for in vitro diagnostic use. This ensures each tube remains uncontaminated and ready for immediate use in laboratory settings, reducing the risk of cross-contamination or sample compromise. The design aligns with standard laboratory workflows, facilitating seamless integration into existing diagnostic processes.

• Is the tube color-coded, and if so, how does this aid identification?

  Yes, the Microtainer Brand Tube with EDTA is color-coded for easy identification in clinical settings. The color-coding helps laboratory staff quickly distinguish it from other tubes, minimizing the risk of mislabeling or incorrect sample handling. This visual cue is particularly useful in fast-paced environments where accuracy and efficiency are critical.

• What storage guidelines should be followed to maintain the tube’s sterility and performance?

  To maintain sterility and integrity, the Microtainer Brand Tube with EDTA should be stored according to the manufacturer’s guidelines. This typically includes keeping the tubes in their original packaging, away from direct sunlight or extreme temperatures, and ensuring the seals remain intact. Proper storage prevents contamination and preserves the tube’s functionality for reliable diagnostic testing.

• Can this tube be reused, and what are the implications of reuse?

  No, the Microtainer Brand Tube with EDTA is designed for single-use only. Reusing the tube could compromise sterility, introduce contamination, or alter the anticoagulant properties of EDTA, leading to inaccurate test results. Single-use design ensures patient safety, sample reliability, and compliance with clinical laboratory standards.