CLASS II ONGOING Device recall · Reported 15 Jan 2025 · FDA Enforcement Report
Access Intact PTH assay, a paramagnetic particle recalled
Beckman Coulter is recalling Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the, distributed nationwide in the US. The recall was initiated on 26 Nov 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0803-2025
- FDA event ID
- 95871
- Recalling firm
- Beckman Coulter, Chaska, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 26 Nov 2024
- FDA classified
- 3 Jan 2025
- Reported
- 15 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 26 Nov 2024 | Recall initiated by company | |
| 3 Jan 2025 | Classified by FDA | +38 days |
| 15 Jan 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems, Catalog Number A16972
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Is Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the recalled?
Yes. Beckman Coulter recalled Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the on 26 Nov 2024. The recall is Class II and its status is Ongoing. Recall number Z-0803-2025.
Why was it recalled?
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.
Which lots are affected?
UDI: (01)15099590201937(17)241130(11)231201; Lot 339071
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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