Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence i...
FDA Device Recall #Z-2923-2018 — Class II — January 12, 2018
Recall Summary
| Recall Number | Z-2923-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 12, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tecan US, Inc. |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 870 (USA) 180 (OUS) |
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.
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.
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.
Lot / 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
Other Recalls from Tecan US, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1851-2019 | Class II | Freedom EVO 200 - Product Usage: It is intended... | Apr 12, 2019 |
| Z-3187-2018 | Class II | Freedom EV0-2 with any version of EVOware and E... | Jul 23, 2018 |
| Z-2661-2016 | Class II | SUNRISE instrument. The INFINITE F50 instrumen... | Jul 25, 2016 |
| Z-2664-2016 | Class II | Tecan Infinite M1000 The Tecan Infinite M1000 ... | Jul 25, 2016 |
| Z-2662-2016 | Class II | Tecan Infinite 200. The SUNRISE instrument is ... | Jul 25, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.