Date Initiated by Firm | August 24, 2015 |
Create Date | October 26, 2015 |
Recall Status1 |
Terminated 3 on January 21, 2021 |
Recall Number | Z-0166-2016 |
Recall Event ID |
72013 |
Product Classification |
Calculator/data processing module, for clinical use - Product Code JQP
|
Product | Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs. |
Code Information |
Software Version 1.6 |
Recalling Firm/ Manufacturer |
Perkin Elmer Life Sciences Inc Laitun 4 Mustionkatu 6 Turku Finland
|
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Software design |
Action | 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 |
Quantity in Commerce | 6 units |
Distribution | US distribution to FL, GA, and NV; and Canada |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|