FDA Device recall Z-0727-2025
Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit by Beckman Coulter, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0727-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-18 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Beckman Coulter |
| Distribution | n/a |
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.
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.
Identifiers
| code_info | UDI/DI 15099590693183, All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0727-2025%22
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