Z-1081-2012

LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood...

Name: Z-1081-2012 LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood...
Creator: Greiner Bio-One North America, Inc.
Published: 2011-12-14
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2011-12-14 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes on 2011-12-14. The reason FDA records is "The lithium heparin tubes may have a contamination with EDTA potassium". 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-1081-2012
Status: Terminated
Initiated: 2011-12-14
Posted: 2012-02-22
Terminated: 2012-06-21
Recalling firm: Greiner Bio-One North America, Inc.
Product: LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110. Venous blood collection tubes.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: The lithium heparin tubes may have a contamination with EDTA potassium.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Greiner Bio-One sent a "RECALL OF LITHIUM HEPARIN TUBES WITH EDTA CONTAMINATION" letter dated December 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete an attached Product Disposition Site Confirmation Form and to fax the form to 800-726-0052. This form will confirm that customers have discarded/destroyed all affected product. The firm will replace the product after receipt of the form. Contact the firm at 800-515-8112 for questions regarding this recall.
Quantity in commerce: 2,082,000 pieces
Distribution: Nationwide Distribution.
Product codes and lots: Item #456087, Lot #B07115 and B08116, Item #454244, #B091112, Item #456087CA, Lot #B091106, Item #456287, Lot #B101114, Item #454237, Lot #B091108 and Item #456287, Lot #B091110.

Product code JKA

K960857Class IIGreiner Vacuette Blood Collection Tube W/lithium Heparin & 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)