ACTIVE RENIN

CISBIO BIOASSAYS · Model RENIN · UDI-DI 03661541510518

CIB Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Radioimmunometric assay kit for the quantitative determination of active renin in human plasma. Contains enough reagents for 100 tests. For in vitro diagnostic. Quantitative determination of active renin is used in the diagnostic and treatment of certain types of hypertensions.

Recalls

Date	Firm	Reason
2012-01-20	Beckman Coulter Inc.	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 co
2009-10-12	Diasorin Inc.	The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
2003-07-28	Perkinelmer Life Sciences, Inc.	Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
2003-07-28	Perkinelmer Life Sciences, Inc.	Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.