FDAFDA · Food and drugs·Recall number Z-0214-2016
Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL)
Published November 11, 2015 · Recall initiated: September 22, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ELITech Clinical Systems SAS
- Distributor
- US Nationwide Distribution
- Lot
- all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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