FDA-Device2012-10-17Class II
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
Beckman Coulter Inc.
Hazard
The recall was initiated because Beckman Coulter has confirmed that the Active Renin IRMA Test Kit may exhibit a decrease in stability of the coated tubes. As a result, quality control and patient sample results may be falsely elevated by up to 72%.
Sold states
Worldwide Distribution - US Natiowide including the state of: OH, CT, CA and the state of Argentina, Austria, Belgium, Brazil, Canada, China, Columbia, Czech Republic, France, Germany, Greece, Hungary, Italy, Kuwait, Netherlands, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.
Affected count
216 units total (6 units in the US)
Manufactured in
250 S Kraemer Blvd, MS/E1.NE.02, Brea, CA, United States
Products
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0016-2013Don't want to check this manually?
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