Beckman Coulter recalls Access Intact PTH assay reagent packs from lot 339071 that may be over- or under-filled, risking inaccurate test results. Affected units were identified through internal testing on April 10, 2024.
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.
Beckman Coulter is recalling Access Intact PTH assay reagent packs from lot 339071 because some packs may be over- or under-filled in well 0. This could cause sealing issues, contamination, instrument errors, delays, or inaccurate test results with negative bias and increased imprecision.
The well 0 scale on the filling line malfunctioned during production for some lot 339071 packs, causing over- or under-filling. This may lead to sealing problems, contamination, instrument errors, delays, or inaccurate test results with negative bias and increased imprecision.
Laboratory users who purchased the Access Intact PTH assay reagent packs from lot 339071 are affected. Those using the reagent packs for parathyroid hormone testing are most at risk of inaccurate results.
Check for the lot number 339071 on the Access Intact PTH assay reagent packs. The product is identified by catalog number A16972 and UDI: (01)15099590201937(17)241130(11)231201.
Look for the lot number 339071 on the Access Intact PTH assay reagent packs.
Beckman Coulter identified that some Access PTH reagent packs from lot 339071 may be over- or under-filled in well 0, which could cause sealing issues, contamination, instrument errors, delays, or inaccurate test results with negative bias and increased imprecision.
Check for the lot number 339071 on the Access Intact PTH assay reagent packs. The product is identified by catalog number A16972 and UDI: (01)15099590201937(17)241130(11)231201.
The recall record does not specify a remedy, so no action is required beyond checking the lot number.
We’ve drafted a message you can send Beckman Coulter to request your refund or repair — edit it as you like.
Subject: Recall Z-0803-2025 — Beckman Coulter Beckman Coulter Hello, I own a Beckman Coulter that is covered by recall Z-0803-2025 from Beckman Coulter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
