FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2763-2019
- Recalling firm
- Beckman Coulter Inc.
- 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.
- Status
- Terminated
- Initiated
- 2018-09-18
- Posted
- not on file
- Terminated
- 2024-02-21
- 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.
- Lot, serial or model codes
- Lot Number 831755.
- 510(k) numbers
- ["K023764","K050202"]
- PMA numbers
- not on file
- Product code
- CGR
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28