Microtainer Brand Sodium Fluoride/Edta Tube with Microgard Closure, Model 365992

• 8 recalls, same reason

  • Terminated Z-0059-2020 FDA Class II ·initiated 13 May 2019
  • Terminated Z-0060-2020 FDA Class II ·initiated 13 May 2019
  • Terminated Z-0056-2020 FDA Class II ·initiated 13 May 2019
  • Terminated Z-0058-2020 FDA Class II ·initiated 13 May 2019
  • Terminated Z-0054-2020 FDA Class II ·initiated 13 May 2019
  • Terminated Z-0055-2020 FDA Class II ·initiated 13 May 2019
  • Terminated Z-0061-2020 FDA Class II ·initiated 13 May 2019
  • Terminated Z-0057-2020 FDA Class II ·initiated 13 May 2019

  Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

• • Terminated Z-0957-2007 FDA Unclassified (pre-2012) ·initiated 17 May 2007 ·on shared 510(k) K002456

  Mislabeling : box and bag labels are incorrectly labeled to indicate the product contains Sodium Fluoride/Potassium Oxalate, however the instructions for use and the product itself are correct in the additive indicated and used (Sodium Fluoride/Na2EDTA).

• • 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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K002456 ↗

FDA Product Code

JKA

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Vacutainer Brand Ppt Plasma Preparation Tube

  Class II

  FDA 510(k) K972075 Active Cleared 24 Feb 1998

• Microtainer Brand Chemistry Tubes with Microgard Closure, Model 365965, 365985, 365963, 365967, 36578

  Class II

  FDA 510(k) K991702 Active Cleared 28 Jul 1999

• Vacutainer Brand Eclipse Blood Collection Needle, Models# 368607 & 368608

  Class II

  FDA 510(k) K982541 Active Cleared 28 Oct 1998

• Vacutainer Plus Tubes

  Class II

  FDA 510(k) K953463 Active Cleared 20 Sep 1995

• Seditainer Erythrocyte Sedimentation Rate (ESR) System

  Class II

  FDA 510(k) K953994 Active Cleared 26 Sep 1995

• Lok-On Needle Disposal System

  Class II

  FDA 510(k) K951886 Active Cleared 30 Jun 1995

See all devices from Becton Dickinson Vacutainer Systems →