Skip to content
Recall Observatory FDA recall evidence

Device product

Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL)

Z-0215-2016

September 22, 2015

Class II

Product summary

Firm
ELITech Clinical Systems SAS
Event
Event 72322
Status
Terminated
Classification
Class II
Quantity
612 total
Official record key
device-enforcement:Z-0215-2016

Official wording

Reason: ELITech clinical Systems reagents based on Trinder reaction used on the Eon 300 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 300 instrument system are recalled due to potential drug interference. No complaints were received.