Device product
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The 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.
Z-2763-2019
Product summary
- Event
- Event 83163
- Status
- Terminated
- Classification
- Class II
- Quantity
- Access Cortisol Reagent Assay
- Official record key
device-enforcement:Z-2763-2019
Official wording
Reason: 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%).
Code information: Lot Number 831755.
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
Derived failure modes
-
Unknown
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%).