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ELITech Clinical Systems SAS Recalls
6 recalls on record · October 8, 2014 to August 8, 2018 · Medical Devices
Recalls by year
14
15
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 8, 2018Medical DevicesFDA
ELITech Clinical Systems SAS recalls ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low l
Hazard: 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.
November 11, 2015Medical DevicesFDA
ELITech Clinical Systems SAS recalls Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 50
Hazard: ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to potential drug interference. No complaints were received.
November 11, 2015Medical DevicesFDA
ELITech Clinical Systems SAS recalls ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method.
Hazard: ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.
November 11, 2015Medical DevicesFDA
ELITech Clinical Systems SAS recalls Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Refere
Hazard: ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to potential drug interference. No complaints were received.
November 11, 2015Medical DevicesFDA
ELITech Clinical Systems SAS recalls Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Refe
Hazard: ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to potential drug interference. No complaints were received.
October 8, 2014Medical DevicesFDA
ELITech Clinical Systems SAS recalls ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AS
Hazard: Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.