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Recall Observatory FDA recall evidence

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

September 18, 2018

Class II

Product summary

Firm
Beckman Coulter Inc.
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

    reason.no_named_rule · v1.0.0

    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%).