—#112672

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.

FDA product code: CIB — Radioimmunoassay, Angiotensin I And Renin
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K981607
Affected lot / code info: Lot # 110919D, 111017C, 111017D, 111114C, 111212C.

Why it was recalled

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%.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, MS/E1.NE.02, Brea, California 92821-6232

Distribution

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.

Timeline

Recall initiated: 2012-01-20
Posted by FDA: 2012-10-05
Terminated: 2012-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112672. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.