Z-2763-2019 Class II Terminated
FDA device recall Z-2763-2019 was initiated by Beckman Coulter Inc. on Sep 18, 2018 and is designated Class II. Reason for recall: 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%). The recall status is terminated (terminated Feb 21, 2024). Affected quantity: Access Cortisol Reagent Assay.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 9, 2019
- Initiation Date
- Sep 18, 2018
- Termination Date
- Feb 21, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Access Cortisol Reagent Assay
Product Description
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.
Reason for Recall
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%).
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
Code Information
Lot Number 831755.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2763-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026