Recall Z-2923-2018 ยท NHG Enzyme Immunoassay, Cortisol, Salivary
Tecan US, Inc.
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.
| Date | Jan 12, 2018 |
| Status | Terminated |
| Reason | 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 | 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 hav |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150528 | Cortisol Saliva Luminescence Immunoassay Ibl International GmbH, Nov 25, 2015 |