Recall Z-2763-2019
Beckman Coulter Inc. · initiated September 18, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot Number 831755.
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%).
FDA-determined cause: Process design
Action taken
An Urgent Medical Device Recall Letter was sent during the week of 9/17/2018 to all affected customers via mail and or email. Customers were instructed to discontinue use and discard remaining product. Customers were also instructed to consider a review of the Cortisol results generated with the affected lot number at the discretion of the Medical Director.
Details
- Recall number
- Z-2763-2019
- Initiated
- September 18, 2018
- Terminated
- February 21, 2024
- Product code
- CGR – Radioimmunoassay, Cortisol
- Quantity
- Access Cortisol Reagent Assay
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
- Recalling firm
- Beckman Coulter Inc., Brea, CA