Recall Z-2764-2019— ELITech Group B.V.

Name: FDA recall Z-2764-2019
Creator: U.S. Food and Drug Administration
Published: 2016-07-12

Class III · Terminated

Class III FDA medical device recall by ELITech Group B.V., initiated 2016-07-12, terminated 2022-02-04. It names one FDA 510(k) clearance: K102647. Product: Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.. Reason: Software malfunction; The action being taken due to the device becoming inoperable due to software lockup..

Recalling firm: ELITech Group B.V.
Classification: Class III
Status: Terminated
Initiated: 2016-07-12
Terminated: 2022-02-04
Firm location: Spankeren, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K102647 — ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...Elitechgroup Vital Scientific BV·cleared 2011-03-24

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

Viva-ProE Systems, Model # 6003-670, UDI: 03661540600357 - Product Usage: The ELITech Clinical Systems Selectra ProM is an automated clinical chemistry system intended for use in clinical laboratories. It is intended to be used for a variety of assay methods that have been applied to spectrophotometric and electrochemical techniques. The system has two core modules: one consisting of a spectrophoto-metric system for measurement of analytes using spectrophotometric techniques, such as end point, rate and turbidometric assays. The second module is an electro-meter used for measurement of electrolytes.

Reason for recall

Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

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