Access hsTnI Reagent, REF B52699, Immunoassay Method… recallZ-0727-2025 · Beckman Coulter, Inc. · initiated Nov 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Component design/selection
What the company is doing
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."
Recall details
- Recall number
- Z-0727-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2024
- Posted by the FDA
- Dec 20, 2024
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 2,109,804 units
- Product code
- MMI
- FDA submissions
- K121214, K172783, K222881, K230648
- Distribution
- Worldwide
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.
Code information (models, lots, serial numbers)
UDI/DI 15099590693183, All Lots
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Access hsTnI B52669Beckman Coulter, Inc. · Immunoassay Method, Troponin Subunit2 recalls170 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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