Access Intact PTH assay, a paramagnetic particle… recallZ-0803-2025 · Beckman Coulter, Inc. · initiated Nov 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
An URGENT MEDICAL DEVICE RECALL notification letter dated 11/26/24 was sent to customers. ACTION: Discontinue using Access Intact PTH reagent lot 339071 and discard all remaining reagent packs from this lot. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to perform a retrospective review of the patient results generated from the affected Access Intact PTH reagent pack lot to determine if retesting is necessary. Beckman Coulter is investigating the root cause of this issue to prevent similar occurrences. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center; From our website: http://www.beckmancoulter.com
Recall details
- Recall number
- Z-0803-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 26, 2024
- Posted by the FDA
- Jan 3, 2025
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 362 units
- Product code
- CEW
- FDA submissions
- K061190
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
Product description
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
Code information (models, lots, serial numbers)
UDI: (01)15099590201937(17)241130(11)231201; Lot 339071
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Access Intact PTH A16972Beckman Coulter, Inc. · Radioimmunoassay, Parathyroid Hormone2 recalls8 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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