Lower risk Medical device recall · FDA · Published November 8, 2024

Beckman Coulter Access Intact PTH Assay Recall: False Low PTH Results Risk

Beckman Coulter recalls Access Intact PTH assay for DxI 9000 analyzer due to false low parathyroid hormone results from prolonged sample storage. This may cause missed diagnoses or delayed treatment.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0673-2025Medical device Beckman Coulter ›

Lower-risk recall

The reason for the recall is that EDTA and lithium heparin plasma samples that are stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before performing the intact PTH (parathyroid hormone) test may produce falsely decreased intact parathyroid hormone results. This could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management, depending upon the patient s clinical condition.

Take action

Contact the company

Recalling firmBeckman Coulter Inc.250 S Kraemer Blvd · Brea, CA 92821-6232

✎ GovInfoNow plain-language explainer

Beckman Coulter is recalling the Access Intact PTH assay for the DxI 9000 Access Immunoassay Analyzer. Storing plasma samples in the sample wheel for too long before testing can cause false low parathyroid hormone results, which might lead to missed diagnoses or delayed treatment. Read more at govinfonow.com/recall/53531-beckman-coulter-access-intact-pth-assay-recall-false-low-pth.

Source Summary by GovInfoNow · govinfonow.com/recall/53531-beckman-coulter-access-intact-pth-assay-recall-false-low-pth · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0673-2025

Cite this page

“Beckman Coulter Access Intact PTH Assay Recall: False Low PTH Results Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53531-beckman-coulter-access-intact-pth-assay-recall-false-low-pth. Based on FDA recall #Z-0673-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0673-2025%22&limit=1).

The FDA announced on November 8, 2024, that Beckman Coulter Inc. is recalling Access Intact PTH assay kits for the DxI 9000 Access Immunoassay Analyzer due to a risk of falsely decreased parathyroid hormone results. The agency issued recall number Z-0673-2025 for this voluntary Class II action.

How to tell if you have it

Brand: Beckman Coulter
Product: Access Intact PTH assay on the DxI 9000 Access Immunoassay Analyzer
Catalog number: A16972
UDI-DI: 15099590201937
Lots: 338921, 339071, 372223, 439138, 439205, 439206, 439207, 439650, 439801, 439889, 440026, 440090, 472012, 472092, 472136, 472154
Units affected: 31 in the US; 167 outside the US

The hazard

EDTA and lithium heparin plasma samples stored in the DxI 9000 Access Immunoassay Analyzer sample wheel for a prolonged period before testing may produce falsely decreased intact parathyroid hormone results. This error could lead to a missed diagnosis, a delay in treatment, or inappropriate clinical management depending on the patient's condition.

Context

GovInfoNow's records show Beckman Coulter, Inc. has had 132 other recalls on record since June 20, 2017. Recent brand recalls include DxC 500i Modules with Software 1.5 (July 15, 2026) and MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026). Other recent recalls of similar products include Beckman Coulter Bicarbonate Reagent (October 14, 2025), Beckman Coulter Emit 2000 Quinidine Assay (July 13, 2026), and Roche Elecsys Anti-TSHR Assay (November 21, 2025).

How to tell if you have this one

Check for the catalog number A16972 on the Access Intact PTH assay. The product was sold with specific lots: 338921, 339071, 372223, 439138, 439205, 439206, 439207, 439650, 439801, 439889, 440026, 440090, 472012, 472092, 472136, 472154.

Brand
Beckman Coulter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Assay Lot Numbers
Verify the lot numbers on your Access Intact PTH assay to see if they match the recalled lots: 338921, 339071, 372223, 439138, 439205, 439206, 439207, 439650, 439801, 439889, 440026, 440090, 472012, 472092, 472136, 472154.

How this recall unfolded

Recall timeline

FDA published this recall 40 days after the firm started it.

Nov 8, 2024Firm started the recall
Dec 11, 2024FDA classified it Class II
Dec 18, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/53531-beckman-coulter-access-intact-pth-assay-recall-false-low-pth">Beckman Coulter Access Intact PTH Assay Recall: False Low PTH Results Risk (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-0673-2025 (November 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0673-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.