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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm December 05, 2016
Date Posted December 22, 2016
Recall Status1 Terminated 3 on February 06, 2017
Recall Number Z-0897-2017
Recall Event ID 75862
Product Classification Severe Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System - Product Code PJI
Product EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on filter paper. The test is for use on the VICTOR" EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
Code Information Lot Number: 1065060401
Recalling Firm/
Manufacturer		 PerkinElmer Health Sciences, Inc.
Manufacturer Reason
for Recall		 Unique Device Identifier (UDI) is missing from outer kit box label.
FDA Determined
Cause 2		 Employee error
Action Customers were notified of the recall via email on December 5, 2016. Technical Support will ensure the customers receive the Recall Letter and understand the recommended actions. Customers were asked to retain this Medical Device Correction in your laboratory documentation until the affected lot inventory is either depleted or reaches expiration and to complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to TurkuQMresponse@perkinelmer.com as soon as possible, but not later than December 29, 2016.
Quantity in Commerce 73 kits
Distribution MA, AK
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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