Beckman Coulter recalls Access Testosterone assay (Catalog 33560) due to cross-contamination risk from inadequate maintenance, potentially causing inaccurate patient results.
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
Beckman Coulter is recalling their Access Testosterone assay (Catalog Number 33560) because improper maintenance of the RPL5 fill line can cause cross-contamination between reagent packs. This could lead to significant errors in patient test results, up to a 34% increase or 23% decrease.
Inadequate preventative maintenance on the RPL5 fill line causes splashing between testosterone reagent packs. This cross-contamination can lead to up to a 34% increase or 23% decrease in patient test results.
Healthcare providers using the Access Testosterone assay (Catalog Number 33560) with serial number 538081 are affected. Patients receiving tests with this specific reagent lot may be at risk of inaccurate results.
Check for the Catalog Number 33560 and Serial Number 538081 on the Access Testosterone assay. The UDI-DI is 15099590231347.
Verify the Catalog Number 33560 and Serial Number 538081 on the Access Testosterone assay.
Inadequate preventative maintenance on the RPL5 fill line led to cross-contamination between testosterone reagent packs, potentially causing up to a 34% increase or 23% decrease in patient results.
Check the Catalog Number 33560 and Serial Number 538081 on the Access Testosterone assay. If you have this specific model, contact Beckman Coulter for guidance.
The recall is for potential inaccurate test results, not a direct safety hazard. There is no mention of injury risk in the official notice.
We’ve drafted a message you can send Beckman Coul: Inc. to request your refund or repair — edit it as you like.
Subject: Recall Z-1901-2025 — Beckman Coul: Inc. Beckman Coul: Inc. Hello, I own a Beckman Coul: Inc. that is covered by recall Z-1901-2025 from Beckman Coul: Inc.. 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.
