Z-0184-2012

Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209

Name: Z-0184-2012 Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209
Creator: Greiner Bio-One North America, Inc.
Published: 2011-08-12
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2011-08-12 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209 on 2011-08-12. The reason FDA records is "Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills". 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-0184-2012
Status: Terminated
Initiated: 2011-08-12
Posted: 2011-11-14
Terminated: 2012-03-12
Recalling firm: Greiner Bio-One North America, Inc.
Product: Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.
Quantity in commerce: 504,000 pieces
Distribution: Nationwide.
Product codes and lots: Item #454209, Lot #B051111.

Product code JKA

K971236Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-12

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)