Access 2 Immunoassay Analyzer motor alignment issue may delay results
Beckman Coulter is recalling Access 2 Immunoassay Analyzers due to sample motor misalignment that may delay patient test result reporting. The recall affects 873 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device with no reported illnesses or injuries. The hazard is operational—potential delay in test result reporting—rather than direct patient harm. Per the rubric, when the hazard is theoretical and no illnesses are reported, the score is at most 3; Class II classification without injury reports indicates Moderate severity.
Plain-English summary
Beckman Coulter, Inc. is recalling the Access 2 Immunoassay Analyzer (Catalog Number 81600N) due to improper alignment of the sample motors (B48016). The misalignment causes the motors to rub against the sample wheelbase plate and index sensor. This issue was traced to a worn tool used in production at the supplier.
The motor rubbing and wear could lead to delays in reporting patient test results. A total of 873 units have been distributed worldwide.
Healthcare facilities with affected equipment should verify their device's serial number against the provided recall list. Customers should contact Beckman Coulter for instructions on inspection, repair, or replacement of affected analyzers. Additional information is available from the FDA under recall number Z-1386-2025.
The recalled product
- Product
- Access 2 Immunoassay Analyzer, Catalog Number 81600N
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 873
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 15099590265380
Distribution
Distributed nationwide across the United States.
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