Class 2 Device Recall Access 2 Reaction Vessels

• Date Initiated by Firm: November 07, 2025
• Date Posted: December 09, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0889-2026
• Recall Event ID: 97932
• 510(K)Number: K121214
• Product Classification: Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
• Product: Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
• Code Information: UDI-DI: 15099590180249; Lot Numbers: P243943, P243971, P244202 P244344, P244345, P250001, P250002, P250003, P250004 and P250005
• FEI Number: 2122870
• Recalling Firm/ Manufacturer: Beckman Coulter, Inc.; 1000 Lake Hazeltine Dr; Chaska MN 55318-1037
• For Additional Information Contact: Ian Pilcher; 952-448-4848
• Manufacturer Reason for Recall: It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
• FDA Determined Cause: Process design
• Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 10/29/25 was sent to customers. Check your inventory of Access 2 RVs for the lots listed at the top of this letter. "If you have the lots listed above contact Beckman coulter for replacement RVs. "You may continue to use the lots listed above until you have received a sufficient supply of replacement RVs. Once replacement RVs arrive, then dispose of the lots listed above according to your local regulations. "If you do not have the RV lots listed above, then no further action is needed. Retrospective review of results is not necessary because this issue does not affect individual patient results. Please contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: "Electronically, if you received this communication via email. "Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: "From our website: http://www.beckmancoulter.com "Contact your local Beckman Coulter Representative for replacement.
• Quantity in Commerce: 38,225 untis
• Distribution: US Nationwide. Global 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 = JJE