Z-2154-2012Class II

3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital...

Name: Z-2154-2012 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital...
Creator: Greiner Bio-One North America, Inc.
Published: 2012-07-02
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2012-07-02 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood... on 2012-07-02. FDA classified it as Class II and gives the reason as "Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests". 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-2154-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-02
Posted: 2012-08-07
Terminated: 2013-06-11
Recalling firm: Greiner Bio-One North America, Inc.
Product: 3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Product code: GIM Tubes, Vacuum Sample, With Anticoagulant
Reason for recall: Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Distributors were notified by letter on 07/02/2012 and customers were sent a letter dated 07/05/2012. The letters identified the affected product and the reason for the recall. Distributors were asked to stop distributing the affected product and to complete the attached Product Disposition form. The form along with the affected product was to be returned to GBO. The firm will provide replacement stock or issue a credit once product return and receipt of the Product Disposition form has been confirmed. Customers were also asked to complete the Product Disposition Site Confirmation form and fax it back to Greiner Bio-One North America, Inc. at the number provided. The letter states that the firm will replace any affected product once the form is received. Questions should be directed to 800-515-8112.
Quantity in commerce: 838.9 cases (1,006,700 pieces)
Distribution: Nationwide Distribution
Product codes and lots: Lot #B041206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2154-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2154-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-15	2012-08-07

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)