Z-2923-2018Class II

Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is...

Name: Z-2923-2018 Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is...
Creator: Tecan US, Inc.
Published: 2018-01-12
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2018-01-12 / Terminated / root cause: manufacturing process

FDA source

Tecan US, Inc. began a recall of Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative... on 2018-01-12. FDA classified it as Class II and gives the reason as "Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard". 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-2923-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-08-24
Terminated: 2020-06-02
Recalling firm: Tecan U.S.
Product: Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. The device is not intended for point-of-care settings.
Product code: NHG Enzyme Immunoassay, Cortisol, Salivary
Reason for recall: Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, IBL International, sent an "Urgent Field Corrective Action" letter dated 1/12/2018 via registered mail to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to examine your stock and affected lots; contact all customers and provide the letter; if you have any of the affected product, stop using and quarantine/scrap all remaining product from lots LCL129 up to LCL 133. Review results generated with affected lots and follow your laboratory standard operational procedures to review any potential aberrant results that may have occurred; complete and return the Customer Response Form by fax to:1-919-287-2961; email to:[email protected] or mail to: Attention: Tecan QA, 9401 Globe Center Dr., Suite 140, Morrisville, North Carolina 27560,United States to confirm receipt and actions. The firm is expect to have a new lot of Cortisol Saliva LUM available to ship by the end of February 2018. if you have any questions, please contact your local Tecan Helpdesk or IBL or Sr. Director Global Regulatory Affairs at 919-943-7118 or email: [email protected].
Quantity in commerce: 870 (USA) 180 (OUS)
Distribution: Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC, and UT; and countries of: Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.
Product codes and lots: In USA RE62119 Lot # LCL129 exp. date: 2017-11-30, RE62119 Lot # LCL133 exp. date: 2019-03-31, and RE62111 Lot # LCL130 exp. date: 2018-03-31. OUS Lot 131, Lot 132

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2923-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2923-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-05	2018-08-24

Product code NHG

K150528Class IICortisol Saliva Luminescence ImmunoassayIbl International GmbH / cleared 2015-11-25

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)