Beckman Coulter AU5800 Clinical Chemistry Analyzer Recall for Labeling Defect
Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers because the diluted detergent tank lacks labeling for the on/off valve disposition.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a labeling omission regarding valve disposition, which fits the rubric criteria for 'packaging-only problems' or minor documentation issues without reported injury or serious health risk.
Plain-English summary
Beckman Coulter Inc. is recalling the AU5800 Clinical Chemistry Analyzer, including all serial numbers. The recall involves 338 units worldwide, with 11 units distributed in the United States and Puerto Rico. The product is an automated chemistry analyzer used to measure analytes in samples.
The recall was initiated because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve. This labeling omission may affect the proper handling or maintenance of the equipment.
The affected units were distributed nationwide in the USA and Puerto Rico, as well as in numerous countries including Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Israel, Australia, India, United Kingdom, Netherlands, Malaysia, Russian Federation, Japan, Taiwan, and Canada. Users of these devices should contact Beckman Coulter for instructions on how to address the labeling issue.
The recalled product
- Product
- Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
- Manufacturer
- Beckman Coulter Inc.
- Hazard
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)
- Models
- Catalogue Numbers: AU5811-01
- A94906
- AU5811-02
- A94907
- AU5811-03
- A94908
- AU5811-04
- A94909
- AU5811-06
- A94910
- AU5821-01
- A94911
- AU5821-02
- A94912
- AU5821-03
- A94913
- AU5821-04
- A94914
- AU5821-06
Distribution
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