Z-0086-06

Serum Blood Collection Tubes

Name: Z-0086-06 Serum Blood Collection Tubes
Creator: Greiner VACUETTE North America
Published: 2005-07-28
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2005-07-28 / Terminated

FDA source

Greiner VACUETTE North America began a recall of Serum Blood Collection Tubes on 2005-07-28. The reason FDA records is "Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0086-06
Status: Terminated
Initiated: 2005-07-28
Posted: 2005-10-22
Terminated: 2005-11-16
Recalling firm: Greiner Bio-One North America, Inc.
Product: Serum Blood Collection Tubes
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Serum Blood Collection tubes found with excess of Blood Clot Accelerator (BCA) solution.
FDA root cause: Other
Action: Consignees were notified by letter on 07/28/2005.
Quantity in commerce: 1623 cases (1,947,600 pieces)
Distribution: Nationwide, Chile, Costa Rica, Ecuador, El Salvador, Nicaragua and Uruguay.
Product codes and lots: Item #455071, Lot #B040513 and Item #455092, Lot #B040503

Product code JKA

K960858Class IIGreiner Vacutte Blood Collection Tube W/ Clot Activator & Gel SeparatorGreiner America, Inc. / cleared 1996-08-30

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)