Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium… recallZ-0408-2026 · Greiner Bio-One North America, Inc. · initiated Aug 8, 2025
Open, Classified
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
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
FDA root cause category: Under Investigation by firm
What the company is doing
Greiner issued an Urgent Product Recall notice to its consignees on 08/19/2025 via email and fax. The notice explained the issue and requested the following: "Immediate Actions Required 1. Stop Distribution & Isolate Inventory Immediately cease distribution of the affected lot and segregate all remaining units. 2. Select ONE of the following notification options: A. Customer Notification by Greiner Bio-One o Complete the attached Product Disposition Site Confirmation form. o Email the form to [email protected] or fax to 877-217-7927. o Provide an Excel list of all customers including, if applicable, subdistributors who received the affected product, containing: . Facility name and address (city, state, ZIP) . Contact name, email, and phone number for Clinical/Laboratory Director or Supply Chain . Date(s) and quantity shipped o Greiner will handle direct customer notification and coordinate product return/credit. B. Customer Notification by Distributor o Use the customer letter provided by Greiner Bio-One. o Contact all customers who received the affected lot, including any sub-distributors. o Conduct follow-up with non-responders and document effectiveness checks per FDA guidance: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/industryguidance-recalls" For questions regarding this recall, please contact: Greiner Bio-One Technical Service, Phone: 800-515-8112, Fax: 877-217-7927, Email: [email protected]
Recall details
- Recall number
- Z-0408-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2025
- Posted by the FDA
- Oct 28, 2025
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 504,000
- Product code
- GIM
- FDA submissions
- K971221
- Distribution
- US Nationwide distribution.
Product description
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Code information (models, lots, serial numbers)
UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026
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.
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