Z-3027-2020Class II

VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P -

Name: Z-3027-2020 VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P -
Creator: Greiner Bio-One North America, Inc.
Published: 2020-08-28
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2020-08-28 / Terminated

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing... on 2020-08-28. FDA classified it as Class II and gives the reason as "Blood collection tubes experienced an issue with separation and clotting". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3027-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-28
Posted: 2020-09-29
Terminated: 2021-06-17
Recalling firm: Greiner Bio-One North America, Inc.
Product: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: 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: Blood collection tubes experienced an issue with separation and clotting
FDA root cause: Under Investigation by firm
Action: Greiner Bio-One North America issued an urgent product recall notification on August 28, 2020. It state the following: 1. Stop distributing the mentioned product (concerned item/lot) immediately and isolate defective products in your facility. 2. Complete the Product Disposition form and fax it to Greiner at 800.726.0052 or email to [email protected]. 3. Greiner will contact you for the return or destruction of the product after receiving the attached Product Disposition Site Confirmation form. Greiner will also use this information to send you replacement stock or issue a credit. 4. Please provide Greiner with a list of your customers that have received the item with this specific lot number. Include: Facility, Address, Key contact, Phone number, Fax, and Date shipped. Please provide this as an Excel file preferably. If this is not possible, please forward the information in any format. If you have additional questions, please call Greiner Technical Service at 800-515-8112.
Quantity in commerce: 1,008,000 pieces
Distribution: US Nationwide distribution including in the states of IL, PA, VA, MO, NY.
Product codes and lots: Lot Number: B2003399

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3027-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3027-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-29

Product code JKA

K081929Class IIVacuette Blood Collection Tube with Clot Activator and Gel SeparatorGreiner Bio-One North America, Inc. / cleared 2008-12-16

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)