Recall Z-0727-2025 ยท MMI Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.
| Date | Dec 20, 2024 (initiated Nov 18, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 2,109,804 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121214 | ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM Beckman Coulter, Inc., Jun 14, 2013 |
| K172783 | Access hs Tnl Beckman Coulter, Inc., Jun 12, 2018 |
| K222881 | Access hsTnI Beckman Coulter, Inc., Dec 18, 2023 |
| K230648 | Access hsTnI Beckman Coulter, Inc., Dec 4, 2023 |