Reported Aug 8, 2018 · Terminated
ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low…
ELITech Clinical Systems SAS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ELITech Clinical Systems SAS · Zone Industrielle des Fourneaux · Sees, N/A · N/A
Is this the product you have?
- 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 Number55117
- Lot codes and dates
Lot number 7038Manufacture date 03/2017Expiration date 02/2019
- Amount recalled
- N/A
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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