Recall Z-0016-2013— Beckman Coulter Inc.

Name: FDA recall Z-0016-2013
Creator: U.S. Food and Drug Administration
Published: 2012-01-20

Class II · Terminated

Class II FDA medical device recall by Beckman Coulter Inc., initiated 2012-01-20, terminated 2012-10-05. It names one FDA 510(k) clearance: K981607. 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.. 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%..

Recalling firm: Beckman Coulter Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-01-20
Terminated: 2012-10-05
Firm location: Brea, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K981607 — ACTIVE RENIN IRMA MODEL NUMBER DSL-25100Diagnostic Systems Laboratories, Inc.·cleared 1998-05-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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%.

Data sourced from openFDA. This site is unofficial and independent of the FDA.