3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334 recallZ-2154-2012 · Greiner Bio-One North America, Inc. · initiated Jul 2, 2012
Class II Terminated All recalls posted in August 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2154-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 2, 2012
- Posted by the FDA
- Aug 7, 2012
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 838.9 cases (1,006,700 pieces)
- Product code
- GIM
- FDA submissions
- K971221
- Distribution
- Nationwide Distribution
Product description
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.
Code information (models, lots, serial numbers)
Lot #B041206
Other devices under the same FDA submission
3 devices cleared under K971221 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Vacuette 454322Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant3 recalls0 reports
- Vacuette 454334Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- Vacuette 454332Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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