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

• 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-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

K991702 ↗

FDA Product Code

JKA

Models / Variants

365965

365985

365963

365967

36578

Device Class

Class II

Regulation

21 CFR Part 862.1675

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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