Discrete Chemistry Analyzer Recalled Due to Carousel Malfunction
Beckman Coulter is recalling 59 units of its Access 2 Immunoassay System Analyzer due to misaligned index wheels causing carousel motion errors that disable the analyzer and cancel patient tests.
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: This is an FDA Class II recall affecting 59 units of clinical laboratory equipment. The defect causes equipment malfunction rather than a direct patient safety hazard.
Plain-English summary
Beckman Coulter, Inc. is recalling 59 units of its Access 2 Immunoassay System Analyzer due to a defect in the reagent carousel module.
The defect involves misaligned index wheels that cause carousel motion errors or QSMC errors during analyzer operation. When these errors occur, the system becomes non-operational and cancels tests, which can delay patient results.
The affected analyzers were distributed worldwide, including to facilities in the United States (Nebraska, Montana, Louisiana, Texas, New York, California, Michigan, Alabama, Illinois) and in Austria, Belgium, Georgia, India, Indonesia, Italy, Korea, Malaysia, Myanmar, Nigeria, Switzerland, and Vietnam. Customers with affected units should contact Beckman Coulter for assistance.
The recalled product
- Product
- Discrete photometric chemistry analyzer for clinical use.
- Manufacturer
- Beckman Coulter, Inc.
- Hazard
- Affected units
- 59
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 (20)
- Catalog Number: 81600N
- C11907
- UDI: 150995901
- Serial Numbers: 574415
- 574440
- 574484
- 574416
- 574441
- 574485
- 574417
- 574442
- 574486
- 574418
- 574443
- 574488
- 574419
- 574444
- 574489
- 574420
- 574445
Distribution
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