Class 2 Device Recall VACUETTE LH Lithium Heparin Separator Tubes

• Date Initiated by Firm: July 29, 2026
• Date Posted: October 21, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0200-2027
• Recall Event ID: 99518
• 510(K)Number: K960857
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)
• Code Information: Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12
• FEI Number: 3001451379
• Recalling Firm/ Manufacturer: Greiner Bio-One North America, Inc.; 4238 Capital Dr; Monroe NC 28110-7681
• For Additional Information Contact: Angela Drysdale; 001-704-7768646
• Manufacturer Reason for Recall: Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 07/29/2026, an "URGENT MEDICAL DEVICE RECALL NOTICE" was emailed to customers informing them that, Greiner Bio-One North America identified a potential ethylenediaminetetraacetic acid (EDTA) contamination issue in a specific lot of VACUETTE Lithium Heparin serum separator tubes. Use of affected tubes may lead to: " Falsely elevated potassium (K+) results " Falsely decreased calcium (Ca++) results Customers are instructed to: " Immediately identify and quarantine all remaining units of item 454008P, lot B26043FM. " Stop using the affected lot for blood collection. " Notify relevant staff (phlebotomy, lab, clinical teams) of this advisory. " Review any recent patient results obtained using this lot. Consider repeat testing with a different lot if results appear inconsistent with clinical presentation. " Follow proper order of draw, and recollection procedures when re-testing. For unused product disposal (if destroyed by customer/distributor) " The unused blood collection tubes contain chemical additives (LH and serum separator). Recommend following OSHA process, and/or your facility's environmental health and safety (EHS) policies and procedures for disposal. For questions or documentation (Acknowledgement and Receipt Form) to Recalls.US@gbo.com or please call 800-515-8112.
• Quantity in Commerce: 860450
• Distribution: U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
• 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 = JKA