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

FDA device recall Z-0727-2025 · posted 2024-12-20 · Open, Classified

Recall details

Recalling firm

Beckman Coulter, Inc.

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.

Action taken

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."

Root cause

Component design/selection

Status

Open, Classified

Product code

MMI

Quantity affected

2,109,804 units

Distribution

Worldwide

Date initiated

2024-11-18

Date posted

2024-12-20

Location

Chaska, MN

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