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Recall Observatory FDA recall evidence

Device product

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)

Z-0214-2016

September 22, 2015

Class II

Product summary

Firm
ELITech Clinical Systems SAS
Event
Event 72322
Status
Terminated
Classification
Class II
Quantity
1389 systems
Official record key
device-enforcement:Z-0214-2016

Official wording

Reason: 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.

Code information: all lots

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.