Safety Alert for CULTURE BOTTLE BACT / ALERT MB - Record 10158120446 - Affected lots 1029125; 1029521.

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.

BioMerieux detected that in the Instructions for Use for BACTAT bottles for BACT culture flasks, in Instructions for Use (document number 9300224A), the following steps were omitted: guidelines for the preparation of the MB Bact flask and the requirement to add 1 ml of enrichment to these bottles BioMerieux is providing to those who have received the affected product an Addendum to the Instructions for Use which includes the omitted information. A risk analysis has determined that the problem of "incorrect quantity or no addition of Enrichment Liquid" has a Moderate Risk, with Critical Severity and a Chance of Occurrence as Occasional. The probability was determined to be Occasional because the customer may make a pipetting error or omit the enrichment liquid during the preparation of the bottles. The probability of a lab error has not changed. Customers accustomed to the use of the product usually have protocols that the staff follows which must contain the appropriate volume of the enrichment liquid. Soon new customers would be more sensitive to this problem. However, new customers have the means to find the correct volume in the following locations: 1) in the Quality Control section of the product label, 2) on the bioMerieux website Bact Alert 3D product line - culture media table; 3) through the BioMerieux Customer Service. Based on the number of false negative claims since version 9300224A was released to the field, the absence of the amount of enrichment liquid volume does not appear to have negatively impacted customers and the risk remains Moderate. Consequently the risk in the field has not changed as a result of this problem. Anvisa is following this action.