Recall Z-0215-2016— ELITech Clinical Systems SAS

Name: FDA recall Z-0215-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-22

Class II · Terminated

Class II FDA medical device recall by ELITech Clinical Systems SAS, initiated 2015-09-22, terminated 2016-03-04. It names one FDA 510(k) clearance: K100525. 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). 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..

Recalling firm: ELITech Clinical Systems SAS
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Terminated: 2016-03-04
Firm location: SEES, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K100525 — ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2Seppim S.A.S.·cleared 2010-12-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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)

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.