Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the… Recall
Issued January 15, 2025 · Beckman Coulter, Inc.
In January 2025, Beckman Coulter, Inc. recalled the Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Beckman Coulter has identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0. The dispensed material in well 0 could be above or below specification, risking sealing issues, contamination, instrument errors, delays, or inaccurate results with a negative bias and increase in imprecision. The issue was confirmed on 10 April 2024 by Beckman Coulter through an internal non-conformance (NC-INT-66585). The well 0 scale on the filling line began malfunctioning on the fill immediately before PTH. The malfunction was not noticed until the majority of PTH was filled.
What you should do
- 1 Stop using Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay 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 15, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall number
- FDA-Z-0803-2025
- 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.