Device Recall Specimen Gate Screenig Center 의 리콜

Recall

72013

Class 2

Z-0166-2016

2015-08-24

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139579

It would be possible for an abnormal analytical test result value from an affected newborn to be reported with a default result interpretation of normal. the analytical test result value would be correct but the interpretation of the test result value would be incorrect.

Perkin Elmer issued the Recall Letter on 8/24/15 delivered to the customer by email .Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures: Ensure all laboratory routine sample testing procedures are followed to avoid procedural anomalies. In the event a procedure anomaly occurs, review the final analytical result and the corresponding interpretation to confirm both are accurate before releasing the report. Once a PerkinElmer reporting error query is available, continue to run the query until the final corrective action is deployed to your site. The final corrective action will involve an installation update to the software. For further information, please contact your local PerkinElmer representative or specimen.gate.support@perkinelmer.com