Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ENVOY 500 ISE CALIBRATOR KIT Recalled by ELITech Clinical Systems SAS Due to ELITech Clinical Systems SAS initiated this recall because...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ELITech Clinical Systems SAS directly.
Affected Products
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
Quantity: N/A
Why Was This Recalled?
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.
Where Was This Sold?
U.S. only. No gov. accounts. No international.
About ELITech Clinical Systems SAS
ELITech Clinical Systems SAS has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report