Device product
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.
Z-0016-2013
Product summary
- Event
- Event 63140
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216 units total (6 units in the US)
- Official record key
device-enforcement:Z-0016-2013
Official wording
Reason: 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%.
Code information: Lot # 110919D, 111017C, 111017D, 111114C, 111212C.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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%.