Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Access Testosterone assay Recalled by Beckman Coulter, Inc. Due to Inadequate preventative maintenance (PM) performed on the scales...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Beckman Coulter, Inc. directly.
Affected Products
Access Testosterone assay, Catalog Number 33560
Quantity: 70 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 1 state: FL
About Beckman Coulter, Inc.
Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report