Access Intact PTH assay, a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of int
FDA device recall Z-0803-2025 · posted 2025-01-03 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- CEW
- Quantity affected
- 362 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Date initiated
- 2024-11-26
- Date posted
- 2025-01-03
- Location
- Chaska, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 (K061190) | Beckman Coulter, Inc. | 2006-09-15 |