Class 2 Device Recall Beckman Coulter Access hsTnI

• Date Initiated by Firm: November 18, 2024
• Date Posted: December 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0727-2025
• Recall Event ID: 95816
• 510(K)Number: K121214 K172783 K222881 K230648
• Product Classification: Immunoassay method, troponin subunit - Product Code MMI
• Product: Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
• Code Information: UDI/DI 15099590693183, All Lots
• 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: Beckman Coulter, Inc. is recalling their Access hsTnI assay, a medical device by correction. The reason for the recall is: high troponin antigen (>55,000 pg/mL) can contaminate an analyzers probe and cause inter-assay carryover due to insufficient washing. The contamination can cause a falsely elevated Access hsTnI result in subsequent sample(s) which can impact patient care (potentially but not limited to unnecessary coronary imaging or diagnostic catheterization) if the result is near the medical decision points.
• FDA Determined Cause: Component design/selection
• Action: Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the issue, impact to patient care, and requested the following actions be taken: " - Follow your established laboratory protocols for analyzing and retesting discrepant samples if an observed Access hsTnI test result does not align with the patient s clinical presentation. - Beckman Coulter recommends reviewing the content of this letter with your laboratory and/or medical director to determine appropriate next steps. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded the affected product listed above to another laboratory, please provide them a copy of this letter."
• Quantity in Commerce: 2,109,804 units
• Distribution: Worldwide
• 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 = MMI