Z-0818-2020Class II

VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P -

Name: Z-0818-2020 VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P -
Creator: Greiner Bio-One North America, Inc.
Published: 2019-11-25
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2019-11-25 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the... on 2019-11-25. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0818-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-25
Posted: 2020-01-17
Terminated: 2020-10-05
Recalling firm: Greiner Bio-One North America, Inc.
Product: VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by email on 11/25/2019. The letter explained the problem and requested the consignees cease distribution and provide a list of their customers for Greiner to contact. The firm is seeking return or on site destruction of the affected product.
Quantity in commerce: 1,002,000 tubes
Distribution: Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Product codes and lots: DI: 29120049204476, Lot number B190338E

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0818-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0818-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-17

Product code JKA

K983952Class IIGreiner Vacuette Blood Collection TubeGreiner Meditech, Inc. / cleared 1998-12-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)