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ELITech Clinical Systems SAS

Complete recall history across all FDA and CPSC categories — 6 total recalls

ELITech Clinical Systems SAS appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by ELITech Clinical Systems SAS

Date Product Reason Class
Apr 18, 2017 ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator... ELITech Clinical Systems SAS initiated this recall because some users of ENVO... Class II
Sep 22, 2015 Eon 300 system includes the following product reference numbers and names: ... ELITech clinical Systems reagents based on Trinder reaction used on the Eon 3... Class II
Sep 22, 2015 Envoy 500 system includes the following product reference numbers and names: ... ELITech clinical Systems reagents based on Trinder reaction used on the Envoy... Class II
Sep 22, 2015 Eon 100 system included the following product reference numbers and names: ... ELITech clinical Systems reagents based on Trinder reaction used on the Eon 1... Class II
Sep 22, 2015 ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems ... ELITech Clinical Systems reagents based on Trinder reaction used on the Selec... Class II
Aug 11, 2014 ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. ... Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 syste... Class III

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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