VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item… recallZ-1714-2020 · Greiner Bio-One North America, Inc. · initiated Mar 12, 2020
Terminated
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
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
FDA root cause category: Process change control
What the company is doing
Greiner Bio-One North America Inc., notified customers on 03/12/2020 via "Urgent Product Recall" letter. The recall letter identified the affected products and requested the users to stop using the product and complete the product disposition site confirmation form. Consignees were asked to discard/destroy the affected products. If you have additional questions, please call our Technical Service at 800-815-8112.
Recall details
- Recall number
- Z-1714-2020
- Status
- Terminated
- Initiated by the company
- Mar 12, 2020
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 1,000,800 units.
- Product code
- GIM
- FDA submissions
- K971221
- Distribution
- US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.
Product description
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Code information (models, lots, serial numbers)
Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vacuette 454322Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant3 recalls0 reports
Other devices under the same FDA submission
2 devices cleared under K971221 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 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 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page