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
| # | Product as published |
|---|---|
| 1 | reference numbers and names |
| 2 | Reference no. 77345- Glucose (GPSL) |
| 3 | Reference no. 77450- Uric acid (AUVD) |
| 4 | Reference no. 77435- Triglycerides (TGML) |
| 5 | Reference no. 77295- Cholesterol (CHVD) |
| 6 | Reference no. 77301- Cholesterol HDL (HDLL) |
| 7 | Reference 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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