CIBClass II

Radioimmunoassay, Angiotensin I And Renin

Clinical Chemistry · 21 CFR 862.1085

MDR events0All time

Recalls4All time

Registered firms3Currently listed

510(k) clearances16All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

4 recall events for this product code

Beckman Coulter Inc.
TerminatedOct 5, 2012
Active Renin IRMA Kit, Part Number DSL25100
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%.
Z-0016-2013 · View FDA record ↗
Diasorin Inc.
TerminatedJun 28, 2010
GammaCoat Plasma Renin Activity 125 I RIA Kit, REF: CA-1533 (100 test kit ), CA-1553 ( 500 test kit), DiaSorin, Stillwater, Minnesota 55082-0285.
The kit control provided with the GammaCoat Plasma Renin Activity kit was labeled with the incorrect range.
Z-1914-2010 · View FDA record ↗
Perkinelmer Life Sciences, Inc.
TerminatedSep 12, 2003
Angiotensin I [125I] Radioimmunoassay Kit, 250 Tube
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
Z-1206-03 · View FDA record ↗
Perkinelmer Life Sciences, Inc.
TerminatedSep 12, 2003
Angiotensin I [125I] Radioimmunoassay Kit, 500 Tube
Incorrect calibration standard value may result in 25% higher assay values for controls and patient samples
Z-1207-03 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

16 clearances for this product code