ELITech Clinical Systems SAS: Medical Device Recall in 2015 - (Recall #: Z-0214-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
Product Description:

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)

Product Classification:

Class II

Date Initiated: September 22, 2015
Date Posted: November 11, 2015
Recall Number: Z-0214-2016
Event ID: 72322
Reason for Recall:

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.

Status: Terminated
Product Quantity: 1389 systems
Code Information:

all lots

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated