U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Calculator/data processing module, for clinical use - Product Code JQP
원인
Module may freeze without generating user warning. there is a potential risk in delay of sample processing, leading to delayed delivery of test results to patients.
조치
On 2/13/18, distributors were notified by emailed Technical Service Bulletin. The recalling firm also released a Customer Letter to be forwarded to final customers (labs) by distributors. The Customer Letter advised users of the issue and informed that the recalling firm would be visiting sites to upgrade the firmware to resolve the issue. All impacted customers were instructed to complete and return the Receipt Confirmation within 7 days.
Contact provided: Giorgia Amabile - Quality Assurance & Regulatory Affairs Manager, giorgia.amabile@inpeco.com, (+41) 91 9118 258.