Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FranceLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list ELITech Clinical Systems SAS with 6 device recalls. The most recent is a device recall dated Apr 18, 2017: ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 18, 2017 | ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/CatalogClass II · ELITech Clinical Systems SAS initiated this recall because some users of ENVOY 500 ISE CALIBRATOR Kit (Part number: 5511 | Device recalls |
| Sep 22, 2015 | ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following prodClass II · ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due | Device recalls |
| Sep 22, 2015 | Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- UriClass II · ELITech clinical Systems reagents based on Trinder reaction used on the Eon 100 instrument system are recalled due to po | Device recalls |
| Sep 22, 2015 | Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT Class II · ELITech clinical Systems reagents based on Trinder reaction used on the Envoy 500 instrument system are recalled due to | Device recalls |
| Sep 22, 2015 | Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric aClass II · ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 instrument system are recalled due to po | Device recalls |
| Aug 11, 2014 | ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for theClass III · Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) | Device recalls |
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