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IDS-iSYS Direct Renin
IMMUNODIAGNOSTIC SYSTEMS LIMITED · Model IS-4800 · UDI-DI 05060169690707
CIB
Prescription
1
510(k) clearances
0
Adverse events
4
Recalls
3
Facilities
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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Get your free API keyRead the docsData 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.