Z-2763-2019Class II

The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent...

Name: Z-2763-2019 The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent...
Creator: Beckman Coulter Inc.
Published: 2018-09-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2018-09-18 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemiluminscent immunoassay. Product Usage: The assay is a... on 2018-09-18. FDA classified it as Class II and gives the reason as "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%)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2763-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-18
Posted: 2019-09-30
Terminated: 2024-02-21
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: CGR Radioimmunoassay, Cortisol
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%).
Root cause tag: manufacturing process
FDA 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 in commerce: Access Cortisol Reagent Assay
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Lithuania, Mexico, Panama, Serbia, South Africa, and Vietnam.
Product codes and lots: Lot Number 831755.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2763-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2763-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-30

Product code CGR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)