FDA recall Z-2763-2019

Beckman Coulter Inc. · Class II · 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.

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

Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.

Key facts

Status
Terminated
Initiation date
2018-09-18
Report date
2019-10-09
Termination date
2024-02-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Brea, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2763-2019