Beckman Coulter recalls Access hsTnI reagent (REF B52699) due to risk of false high troponin results affecting patient care. Contamination may cause unnecessary cardiac imaging or procedures.
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.
Beckman Coulter is recalling their Access hsTnI reagent (REF B52699) because high troponin antigen contamination can cause false high results in subsequent tests. This may lead to unnecessary cardiac imaging or procedures if results are near critical decision points.
The reagent can become contaminated with high troponin antigen (>55,000 pg/mL), which may cause false high results in subsequent tests. This contamination could lead to unnecessary cardiac imaging or procedures if the results are near critical decision points for patient care.
Healthcare facilities using the Access hsTnI reagent (REF B52699) for cardiac troponin testing are affected. Patients receiving results from contaminated tests may be at risk of unnecessary procedures.
Check for the reagent code REF B52699 on the product label. The recall applies to all lots of this reagent, as indicated by the UDI/DI number 15099590693183.
Look for the reagent code REF B52699 on the product label to confirm if it is recalled.
The reagent can become contaminated with high troponin antigen (>55,000 pg/mL), causing false high results in subsequent tests which may lead to unnecessary cardiac procedures.
False high troponin results could lead to unnecessary cardiac imaging or procedures if results are near critical decision points for patient care.
Check for the reagent code REF B52699 on the product label. The recall applies to all lots with UDI/DI number 15099590693183.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0727-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0727-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
