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.
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Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/52346-beckman-coulter-access-testosterone-assay-recall-cross-contamination-risk.
“Beckman Coulter Access Testosterone Assay Recall: Cross-contamination Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/52346-beckman-coulter-access-testosterone-assay-recall-cross-contamination-risk. Based on FDA recall #Z-1901-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1901-2025%22&limit=1).
The FDA announced on May 5, 2025, that Beckman Coulter, Inc. is recalling the Access Testosterone assay, Catalog Number 33560, due to potential cross-contamination that could skew patient results. The agency issued recall number Z-1901-2025 for the voluntary Class II recall.
How to tell if you have it
Brand: Beckman Coulter, Inc.
Product: Access Testosterone assay
Catalog Number: 33560
Serial Number (Lot): 538081
UDI-DI: 15099590231347
The hazard
Inadequate preventative maintenance on the scales of the RPL5 fill line led to splashing and cross-contamination between wells of testosterone reagent packs. This defect could potentially result in up to a 34% increase or a 23% decrease in patient results.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026). Additional recent recalls include Beckman Coulter Emit 2000 Quinidine Assay (July 13, 2026), Beckman Coulter Bicarbonate Reagent (October 14, 2025), and Tosoh ST AIA-Pack Testosterone (June 12, 2026).
How to tell if you have this one
Check for the Catalog Number 33560 and Serial Number 538081 on the Access Testosterone assay. The UDI-DI is 15099590231347.
Brand
Beckman Coul: Inc.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the Catalog Number 33560 and Serial Number 538081 on the Access Testosterone assay.
Where it went and when
Where it was distributed
Distributed in Florida, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US State: FL. UAE, Vietnam” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1901-2025 (May 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1901-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.