Beckman Coulter Inc.: Medical Device Recall in 2012 - (Recall #: Z-0016-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: January 20, 2012

Date Posted: October 17, 2012

Recall Number: Z-0016-2013

Event ID: 63140

Reason for Recall:

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%.

Status: Terminated

Product Quantity: 216 units total (6 units in the US)

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.

Voluntary or Mandated:

Voluntary: Firm initiated