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.
Recall
- Recall Number
- Z-0016-2013
- Event Number
- 63140
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- CIB
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 20, 2012
- Posted
- October 5, 2012
- Terminated
- October 5, 2012
- Address
- 250 S Kraemer Blvd, MS/E1.NE.02, Brea, CA, 92821-6232
Description
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.
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%.
Beckman Coulter sent an Urgent Production Correction letter dated January 10, 2012 to all their customers who purchased the Manual Immunoassay Active Renin IRMA Test Kit. The letter provides the customers with an explanation of the problem and actions to be taken. Customers were instructed to discontinue use and discard all remaining affected inventory. Customers were asked to complete and return the enclosed Response Form with in 10 days. Customers with questions contact Customer Service Support at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633.
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.
216 units total (6 units in the US)