Safety Alert for Trade name: cobas and 602 modules, cobas and 601 and E170. Technical Name: Physiological Fluid Analyzer. ANVISA registration number: 10287410597; 10287410878; 10287410671; Risk class: I and II. Affected Model:. Serial numbers affected: 4745922001, 5990378001, 4998642001, 3617505001

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.

RECOMMENDATION TO USERS AND CUSTOMERS: Whenever an "Abnormal L2-line Movement" alarm (P. Pipetting level) is issued by the system and the immunochemistry module (cobas and 602 module, cobas and 601, and E170) is in "Pipette Stop", perform the following steps to determine if a sample result mismatch (provided the "Tip / Cup pick up error" alarm has occurred a few minutes before the "Abnormal L2- line Movement ": 1) Collect the remaining racks of the system. Stand-Alone Systems: a) Wait until the system status becomes Stand-By. b) Perform the "Reset or Rack Reset" to collect the racks for Unloader. Systems connected to laboratory automation: a) Stop sending automation racks from the lab and wait until all results to measure the sample output. b) Press the "Stop" button to make the system status enabled for Stand-By. c) Perform the "Reset or Rack Reset" "Reboot or Reboot Racks" to collect the racks for Unloader. 2) Identify and handle the misconfigured rack and incompatible samples Appendix 1 "Identifying and Handling Possible Alternate Sampling Results in cobas e602" Appendix 2 "Identifying and Handling Possible Alternate Sampling Results in cobas e601" Attachment 3 " How to Identify and Treat Possible Alternate Sample Results on the E170 "3) Delete the sample measurement results that were identified as incompatible on the Workplace> Data Review screen. 4) Perform measurements again for the identified samples. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 06/22/2017 - Date of notification notice to Anvisa: 07/24/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "