Reported Oct 17, 2012 · Terminated
Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Active Renin IRMA Kit
- Part Number DSL25100 Product UsageThe 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
- Lot codes and dates
Lot # 110919D111017C111017D111114C111212C
- Amount recalled
- 216 units total (6 units in the US)
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
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%.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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