Beckman Coulter, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0727-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma.

Product Classification:

Class II

Date Initiated: November 18, 2024

Date Posted: January 1, 2025

Recall Number: Z-0727-2025

Event ID: 95816

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.

Status: Ongoing

Product Quantity: 2,109,804 units

Code Information:

UDI/DI 15099590693183, All Lots

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated