Class 2 Device Recall Greiner BIOONE

• Date Initiated by Firm: August 08, 2025
• Date Posted: October 28, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0408-2026
• Recall Event ID: 97457
• 510(K)Number: K971221
• Product Classification: Tubes, vacuum sample, with anticoagulant - Product Code GIM
• Product: Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
• Code Information: UDI-DI: 29120017574488(Rack), 39120017574485(Case). Lot: B250139Q, Expiration: 01/09/2026
• FEI Number: 3001451379
• Recalling Firm/ Manufacturer: Greiner Bio-One North America, Inc.; 4238 Capital Dr; Monroe NC 28110-7681
• For Additional Information Contact: Greiner Bio-One Technical Service; 800-515-8112
• Manufacturer Reason for Recall: 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 Determined Cause: Under Investigation by firm
• Action: 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
• Quantity in Commerce: 504,000
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GIM