Z-1498-06

Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24...

Name: Z-1498-06 Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24...
Creator: Greiner Bio-One North America, Inc.
Published: 2006-08-02
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2006-08-02 / Terminated

FDA source

Greiner Bio-One North America, Inc. began a recall of Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged *... on 2006-08-02. The reason FDA records is "Coagulation tubes found with no additive". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1498-06
Status: Terminated
Initiated: 2006-08-02
Posted: 2006-09-13
Terminated: 2007-01-11
Recalling firm: Greiner Bio-One North America, Inc.
Product: Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA
Product code: GIM Tubes, Vacuum Sample, With Anticoagulant
Reason for recall: Coagulation tubes found with no additive.
FDA root cause: Other
Action: Consignees were notified by letter via fax starting 08/02/2006.
Quantity in commerce: 160 cases (192000 pieces)
Distribution: Nationwide
Product codes and lots: Item #454332, Lot #B050609

Product code GIM

K971221Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-02

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)