VACUETTE Coagulation Tube (Greiner) – label misplacement (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Brand
Greiner Bio-One North America, Inc.
Lot Codes / Batch Numbers
UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026
Products Sold
UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026
Greiner Bio-One North America, Inc. is recalling Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 due to Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 recalls.us@gbo.com 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: recalls.us@gbo.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026