Tecan US, Inc.: Medical Device Recall in 2018 - (Recall #: Z-2923-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 12, 2018

Date Posted: September 5, 2018

Recall Number: Z-2923-2018

Event ID: 80554

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.

Status: Terminated

Product Quantity: 870 (USA) 180 (OUS)

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated