Alerta De Seguridad para ACCESS THYROGLOBULIN CALIBRATORS, Registration No. 10033120496, Lots 325451, 327168 and 330203

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.

This problem can result in high patient and quality control results. The false control results and the patient's thyroglobulin may lead to an additional test. Based on the internal test, the observed increase in results ranged from 11% to 18% when the calibrators were reconstituted with 2.0 mL of distilled water and allowed to stand for 30 minutes prior to use. All levels of control and patient outcomes were affected. The percentage increase in response observed depends on the reconstitution time before use for the affected lots. A reconstitution time of 1 hour and 40 minutes or more using the affected batches provided appropriate recovery of control and patient outcomes. ///// UPDATE - 4/3/2014 - The company forwarded a response letter to all customers who received the aforementioned lots informing them of the necessary actions and forwarded an uncommitted lot. If any service still has lots quoted in this alert, please contact the company.