Reported Nov 11, 2015 · Terminated

Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL)…

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 lndustrielle · SEES, N/A · N/A

Is this the product you have?

7 of 7 products

Products covered by this recall
#Product as published
1reference numbers and names
2Reference no. 77345- Glucose (GPSL)
3Reference no. 77450- Uric acid (AUVD)
4Reference no. 77435- Triglycerides (TGML)
5Reference no. 77295- Cholesterol (CHVD)
6Reference no. 77301- Cholesterol HDL (HDLL)
7Reference no. 77310- Cholesterol, LDL (LDLL)
Lot codes and dates
  • all lots
Amount recalled
1389 systems

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 4, 2016 · Data as of Sep 19, 6:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.