Z-0623-2011

Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238...

Name: Z-0623-2011 Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238...
Creator: Greiner Bio-One North America, Inc.
Published: 2010-08-25
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2010-08-25 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection... on 2010-08-25. The reason FDA records is "Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results". 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-0623-2011
Status: Terminated
Initiated: 2010-08-25
Posted: 2010-12-16
Terminated: 2012-05-15
Recalling firm: Greiner Bio-One North America, Inc.
Product: Vacuette 2 ml Lithium Heparin, Collection Tube, Manufactured by: Greiner-Bio One North America, Inc., 4238 Capital Drive, Monroe, NC. Venous blood collection tubes.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Greiner Bio-One instructed customers to stop distribution and to complete an attached Product Disposition form and return it via fax to Greiner Bio-One. They were further instructed to destroy any product they may have. Distributors were instructed provide a list of their customers that have received the affected item via Excel file so that they can be notified of the recall.
Quantity in commerce: 18 cases (total 21,600 pieces)
Distribution: Nationwide Distribution: USA, including the states of CA, FL, IL, IN, KS, KY, ND, NE, NH, OH, SC, SD and WI.
Product codes and lots: Item number: 454237, Lot number: B061006

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)