Greiner Vacuette Blood Collection Tube

• • Ongoing Z-0571-2026 FDA Class II ·initiated 19 Aug 2025

  Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

• • 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-0818-2020 FDA Class II ·initiated 25 Nov 2019

  The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.

510(k) Number

K983952 ↗

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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  FDA 510(k) K991843 Active Cleared 25 Jun 1999

See all devices from Greiner Meditech, Inc. →