Recall Z-2763-2019 ยท CGR Radioimmunoassay, Cortisol
Beckman Coulter Inc.
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.
| Date | Sep 18, 2018 |
| Status | Terminated |
| 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%). |
| Root cause | Process design |
| Action | 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. |
| Quantity | Access Cortisol Reagent Assay |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam. |
| FDA record | Open on fda.gov |