Safety Alert for Diagnostic Kit IMMULITE 2000/2000 XPi GI-MA (CA 19-9), Risk Class III, Registration: 10345160776, Batches 312 and 313. All products are in stock.

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.

Other clarifications from the company regarding the problem encountered are: - While recovery with patient samples for batches of individual kits continues to meet Siemens' quality control specifications, it has been observed that lot 311 at the lower limit and lot 312 at the upper limit of the curve, are resulting in higher than expected values ​​due to the difference between the two kits. - When comparing lot 312 with lot 311, Siemens observed a mean bias of 38% (ranging from 30% to 47%) for patient samples recovering from 29.6 to 44.4 U / mL and an average of 5% bias (range of 1% to 11%) for patient samples recovering from 540 to 660 U / mL. In future batches of kits, recovery of Quality Control and patient samples similar to lot 312 are expected. - The health risk is related to a delay in the test if the laboratories choose not to perform the test for more than one month. It is limited to a potential delay in radiographic tests if the biochemical tests indicate the recurrence of the disease. If the labs continue with the test, there may be a potential for additional radiographic examination. However, this will not lead to a health risk.