Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the… Recall
Issued January 1, 2025 · Beckman Coulter, Inc.
In January 2025, Beckman Coulter, Inc. recalled the Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Access hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Beckman Coulter, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Beckman Coulter, Inc.
- Category
- Health
- Recall date
- January 1, 2025
- Units affected
- Not reported
- Sold at
- Worldwide
- Recall number
- FDA-Z-0727-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Beckman Coulter, Inc. has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.