Class 2 Device Recall VACUETTE TUBE 4 mL FX Sodium Fluoride/Potassium Oxalate

• Date Initiated by Firm: December 12, 2023
• Date Posted: January 16, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0733-2024
• Recall Event ID: 93606
• 510(K)Number: K971239
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
• Code Information: Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.
• FEI Number: 3001451379
• Recalling Firm/ Manufacturer: Greiner Bio-One North America, Inc.; 4238 Capital Dr; Monroe NC 28110-7681
• Manufacturer Reason for Recall: Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
• FDA Determined Cause: Software design
• Action: Distributors were emailed the notification letter dated 12/11/2023 on 12/12/2023 and the other consignees were sent the letter on 12/13-14/2023 via email or USPS. The distributor letter explained the issue, identified the product, the potential health hazard, informed the consignee they should not use the tubes, and requests use of the product immediately be stopped and the product be isolated in their facility. The consignee should assess the risks and consequences of the use of the defective product in accordance with their procedures and take appropriate action. The enclosed Product Disposition Site Confirmation form is to be returned via email or FAX to confirm the consignee has discarded/destroyed all recalled product in their possession. Distributors were informed that their customers should notified and the letter requests the distributor to provide the recalling firm with a list of their customers who received the product along with the date and quantity that was shipped to the customer. The letter going to other customers provided the same information as the distributor letter except no subrecall information was mentioned within the letter, but the response form requests any facility or location to whom the tubes were forwarded should be advised of the recall and the names of those facilities/locations were to be provided to the recalling firm.
• Quantity in Commerce: 495,600 tubes
• Distribution: US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, 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