Z-0016-2013Class II

Active Renin IRMA Kit, Part Number DSL25100

Name: Z-0016-2013 Active Renin IRMA Kit, Part Number DSL25100
Creator: Beckman Coulter Inc.
Published: 2012-01-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-01-20 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative... on 2012-01-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0016-2013
Classification: Class II
Status: Terminated
Initiated: 2012-01-20
Posted: 2012-10-05
Terminated: 2012-10-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CIB Radioimmunoassay, Angiotensin I And Renin
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%.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 216 units total (6 units in the US)
Distribution: 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.
Product codes and lots: Lot # 110919D, 111017C, 111017D, 111114C, 111212C.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0016-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0016-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-05

Product code CIB

K981607Class IIActive Renin Irma Model Number Dsl-25100Diagnostic Systems Laboratories, Inc. / cleared 1998-05-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)