Reported Mar 26, 2025 · Ongoing
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter, Inc. · 1000 Lake Hazeltine Dr · Chaska, MN · 55318-1037
Is this the product you have?
Access 2 Immunoassay AnalyzerCatalog Number 81600N
- Lot codes and dates
- UDI-DI15099590265380
- Serial Numbers
873 of 873 codes
574626574627574839574840574841574842574852574853574854574378573724574432574538574907574497574303574184574218574219574305574332574333574345574346574414574451574581574582574583574584574726574727574728574729574730574731574732574733574920574922574923574955574957574958574959574984574985574986574987574811574160574161574167574168574169574171574177574178574179574180
- Amount recalled
- 873 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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