Beckman Coulter Recalls Microalbumin Reagent Due to Potential Out-of-Range Recovery
Beckman Coulter is recalling Microalbumin Reagent Lot M609458 because it may recover outside the lower limit of the published insert range for Urine Protein Control Level 1.
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: The recall is classified as FDA Class II, and the source text describes a potential deviation from the published insert range without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Beckman Coulter Inc. is recalling Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL, Lot M609458. The product is intended for the quantitative determination of Albumin concentration in human urine when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator.
The recall was initiated because the company confirmed that the specific lot may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. This issue may affect the accuracy of test results.
A total of 3,158 units were distributed, with 1,957 units distributed in the United States. The product was distributed nationwide in the US and internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and the United Kingdom. Users should stop using the affected lot and contact Beckman Coulter for further instructions.
The recalled product
- Product
- Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
- Manufacturer
- Beckman Coulter Inc.
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)
- M609458
Distribution
Distributed nationwide across the United States.
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