ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x ...
FDA Device Recall #Z-2591-2018 — Class II — April 18, 2017
Recall Summary
| Recall Number | Z-2591-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 18, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ELITech Clinical Systems SAS |
| Location | Sees, N/A |
| Product Type | Devices |
| Quantity | N/A |
Product Description
ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117
Reason for Recall
ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 55117), for Envoy 500 systems are observing trouble while calibrating with some vials. Users contacted the firm when they received the messages "ISE OUT OF REPRODUCIBILITY" or "ISE SLOPE OUT OF RANGE" (i.e., failed calibration). This has resulted in delay in obtaining patient results until the calibrator lot is replaced.
Distribution Pattern
U.S. only. No gov. accounts. No international.
Lot / Code Information
Lot number 7038 , Manufacture date 03/2017, Expiration date 02/2019
Other Recalls from ELITech Clinical Systems SAS
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0216-2016 | Class II | ELITech Clinical Systems reagents used on the S... | Sep 22, 2015 |
| Z-0214-2016 | Class II | Eon 100 system included the following product r... | Sep 22, 2015 |
| Z-0217-2016 | Class II | Envoy 500 system includes the following product... | Sep 22, 2015 |
| Z-0215-2016 | Class II | Eon 300 system includes the following product r... | Sep 22, 2015 |
| Z-0006-2015 | Class III | ENVOY 500 AST Reagent Kit, reference Model/Cata... | Aug 11, 2014 |
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.