LABMAX 240 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

It has been found that lot 09/3880 of the O'ring 10 mm Labmax 240 product (Labtest 17173 code) may not work properly when installed in the equipment. The malfunction of this component allows the formation of bubbles in the body of the pumps of the modules SP, RP, PWP and CWP or the leakage of liquids, causing the loss of reproducibility of the analyzer. We note that the problem was identified only in lot 09/3880, with different batches being used without any restriction. Items collected will be restarted as soon as a new batch is available. Any clarification please contact the Automation Technical Assistance at 0800 031 34 11. Source: Labtest Diagnóstica S / A. Anvisa is accompanying the action of collecting such equipment.