FDAFDA · Food and drugs·Recall number Z-0016-2013
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.
Published October 17, 2012 · Recall initiated: January 20, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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%.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- Lot # 110919D, 111017C, 111017D, 111114C, 111212C.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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