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Greiner Vacutte Blood Collection Tube W/ Clot Activator & Gel Separator

by Greiner America, Inc.

510(k) K960858

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 NumberK960858 Date30 Aug 1996ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2375-2024 FDA Class II initiated 14 May 2024

    The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.

    • Terminated Z-0086-06 FDA Unclassified (pre-2012) initiated 28 Jul 2005

    Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.

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  • Withdrawn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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