Beckman Coulter PTH Assay Reagent Packs Recalled for Filling Defects
Beckman Coulter is recalling Access PTH assay reagent packs from lot 339071 due to under- or over-filling in well 0, which could cause sealing issues, contamination, and inaccurate test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a confirmed manufacturing defect in diagnostic test reagent packs that could produce inaccurate patient test results. No illnesses, injuries, or deaths have been reported.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Intact PTH assay reagent packs (Catalog Number A16972) from lot 339071. The PTH assay is a diagnostic test used to measure parathyroid hormone levels in blood samples using Access Immunoassay Systems.
Some reagent packs from this lot may be over- or under-filled in well 0, the initial chamber in the reagent pack. When the dispensed material in well 0 is above or below specification, it can cause sealing issues, contamination, instrument errors, or inaccurate test results with a negative bias and increased imprecision. The filling line malfunction was discovered on April 10, 2024.
The affected lot was distributed worldwide, including throughout the United States and Canada, totaling approximately 362 units. The recall affects laboratories and healthcare facilities using Beckman Coulter Access Immunoassay Systems.
The recalled product
- 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
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 362
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)15099590201937(17)241130(11)231201
- Lot 339071
Distribution
Distributed nationwide across the United States.
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