Lower riskMedical device recall · FDA · Published February 5, 2025
Beckman Coulter Access 2 Immunoassay Analyzer Recall: Motor Alignment Issue May Delay Test
Beckman Coulter recalls Access 2 Immunoassay Analyzers with specific serial numbers due to a motor alignment issue that could delay patient test results. Affected units have a worn production tool causing sample motor misalignment.
Beckman Coulter identified that an issue for Access 2 Sample Motors (B48016) due to improper alignment, causing the motors to rub against the sample wheelbase plate and index sensor. The issue was traced to a worn tool used in production (at the supplier), affecting Access 2 sample motors. This could lead to a potential delay in reporting patient test results.
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Contact the company
📍Recalling firmBeckman Coulter, Inc.1000 Lake Hazeltine Dr · Chaska, MN 55318-1037
“Beckman Coulter Access 2 Immunoassay Analyzer Recall: Motor Alignment Issue May Delay Test.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52972-beckman-coulter-access-2-immunoassay-analyzer-recall-motor-alignment-issue. Based on FDA recall #Z-1386-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1386-2025%22&limit=1).
The FDA announced on Feb. 5, 2025, that Beckman Coulter, Inc. is recalling Access 2 Immunoassay Analyzers due to a potential delay in reporting patient test results. The recall affects units with specific serial numbers distributed worldwide.
Beckman Coulter identified that improper alignment of the Access 2 Sample Motors causes them to rub against the sample wheelbase plate and index sensor. This issue, traced to a worn production tool at the supplier, could lead to a potential delay in reporting patient test results.
Context
GovInfoNow's records show Beckman Coulter has issued 132 other recalls since June 20, 2017. Recent recalls include the July 15, 2026, DxC 500 AU Modules recall for software defects and the June 26, 2026, MicroScan LabPro V5.03 Panel Update recall for incorrect algorithms. Other recent recalls of similar products include the Jan. 30, 2026, AU5800 Chemistry Analyzer recall and the Jan. 30, 2026, DxC 700 AU recall.
How to tell if you have this one
Check if your Access 2 Immunoassay Analyzer has the catalog number 81600N and the listed serial numbers (574626 through 574999, with specific numbers provided in the recall).
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Verify your Access 2 Immunoassay Analyzer's serial number against the list of affected numbers provided in the recall.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 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-1386-2025 (February 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1386-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.