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Greiner Vacuette Blood Collection Tube

by Greiner America, Inc. 4 variants

510(k) K971239

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK971239 Date12 May 1997ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0733-2024 FDA Class II initiated 12 Dec 2023

    Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.

    • Terminated Z-1923-2016 FDA Class II initiated 26 Apr 2016

    The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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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