Z-0727-2025Class II

Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of...

Name: Z-0727-2025 Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of...
Creator: Beckman Coulter, Inc.
Published: 2024-11-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-11-18 / Open, Classified / root cause: design

FDA source

Beckman Coulter, Inc. began a recall of Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the quantitative determination of cardiac troponin I (cTnI) levels in human serum... on 2024-11-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0727-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-18
Posted: 2024-12-20
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: MMI Immunoassay Method, Troponin Subunit
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.
Root cause tag: design
FDA 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 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
Product codes and lots: UDI/DI 15099590693183, All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0727-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0727-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

Product code MMI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)