ELITech Clinical Systems SAS: Medical Device Recall in 2015 - (Recall #: Z-0215-2016)

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 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)

Product Classification:

Class II

Date Initiated: September 22, 2015

Date Posted: November 11, 2015

Recall Number: Z-0215-2016

Event ID: 72322

Reason for Recall:

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.

Status: Terminated

Product Quantity: 612 total

Code Information:

all lots

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated