Reported Oct 9, 2019 · Terminated
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent…
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?
- The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay
- Product UsageThe assay is a paramagnetic particle, chemiluminescent immunoassay for the quanitative determination of cortisol levels in human serum, plasma (heparin, EDTA) and urine using the Access Immunoassay Systems
- Lot codes and dates
- Lot Number 831755.
- Amount recalled
- Access Cortisol Reagent Assay
Where it was sold
- Nationwide
Why it was recalled
Cross contamination may have occurred between wells for the reagent pack. As a result of this defect, patient results may be negatively impacted (falsely decreased) by up to 16%).
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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