Z-0803-2025Class II

Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative...

Name: Z-0803-2025 Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative...
Creator: Beckman Coulter, Inc.
Published: 2024-11-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2024-11-26 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin... on 2024-11-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0803-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-26
Posted: 2025-01-03
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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
Product code: CEW Radioimmunoassay, Parathyroid Hormone
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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
Quantity in commerce: 362 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI: (01)15099590201937(17)241130(11)231201; Lot 339071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0803-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0803-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-15	2025-01-03

Product code CEW

K061190Class IIAccess Intact Pth and Calibrators, Models a 16972 and a 16953Beckman Coulter, Inc. / cleared 2006-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)