Safety Alert for CRYSTAL ENTERICO NA FERMENTADOR (E / NF) ID KIT AND ACCESSORIES - Registration 10033430047 - AFFECTED LOTS: 2101435; 2104316; 2129487; 2163211.

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.

The product Enteric Crystal Non Fermenter ID Kit and Accessories is a miniaturized microorganism identification system, which employs conventional modified and chromogenic substrates. It is used for the purpose of identifying gram-negative aerobic bacteria belonging to the family Enterobacteriaceae as well as the most frequent isolates of gram-negative fermentative and non-fermenting glucose bacilli. Many of the tests used are modifications of the classical identification methods. This includes tests for fementation, oxidation, degradation and hydrolysis of various substrates. The research and development area of ​​the product factory evaluated the effect of the inverted position of Citrate and Malonic Acid substrates and found that the results presented were inconclusive either because they did not identify the microorganism or because they identified multiple microorganisms. In the latter case, the correct micro-organism always represented one of the results obtained. In cases of inconclusive results, the user will need to use another method or a combination of methods to be able to determine the correct identification of the microorganism. No incorrect identification results were found during the R & D tests or through reports of customer complaints. However, since the identification of other microorganisms that require the use of these two substrates can also be affected and because it is not possible to verify all possible results of the Crystal system, there is a remote chance of incorrect identification and, therefore, situation was classified as critical severity and of remote occurrence. The possible consequences of the use of the affected product are the failure to identify the microorganisms. Studies conducted by the R & D area; did not find incorrect results when the citrate and malonic acid substrates were inverted. Although it is not possible to state that an incorrect result will not occur based on the tests performed, it is more likely that in this situation an inconclusive result will be found for the identification of microorganisms. Anvisa follows this Field Action. UPDATE 08/23/2013 - The company finalized the collection of the remaining products in the market. Product has expired on 3/13/2013.