Beckman Coulter, Inc. recalls Access Intact PTH assay

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.

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

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

• FDA enforcement recordOfficial FDA database entry for Z-0803-2025
• FDA 510(k) clearance · K061190The device's official FDA premarket clearance record
• FDA device classification · CEWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1545The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Beckman Coulter, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.