TROPONIN I TURBO IMMULITE / IMMULITE 1000, Kit for 100 tests, Registration 10345160677, lots 0319; 0321; 0322 and 0323. 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.

The overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as a medium risk to health, its severity being moderate and its probability of occurrence probable. The use of the batches of affected reagents may lead to an increase in the frequency of falsely elevated troponin values. Quality control is unlikely to detect this problem. A falsely elevated troponin value may lead to additional treatment or unnecessary diagnostic procedure. Siemens is recommending a review for any troponin sample that is in the sample stability period, and with troponin values ​​higher than the cut-off established by the laboratory, or greater than the 99th percentile, and which has not been confirmed by another method.