FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0727-2025
- Recalling firm
- Beckman Coulter, 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.
- Status
- Open, Classified
- Initiated
- 2024-11-18
- Posted
- 2024-12-20
- Terminated
- not on file
- 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 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
- 2,109,804 units
- Distribution
- Worldwide
- Lot, serial or model codes
- UDI/DI 15099590693183, All Lots
- 510(k) numbers
- ["K121214","K172783","K222881","K230648"]
- PMA numbers
- not on file
- Product code
- MMI
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28