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U.S. Department of Health and Human Services

Class 2 Device Recall Specimen Gate Screenig Center

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  Class 2 Device Recall Specimen Gate Screenig Center see related information
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.
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