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.
Recall
- Recall Number
- Z-2763-2019
- Event Number
- 83163
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- CGR
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- September 18, 2018
- Terminated
- February 21, 2024
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
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.
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%).
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.
Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
Access Cortisol Reagent Assay