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U.S. Department of Health and Human Services

Class 3 Device Recall PerkinElmer 226 Sample Collection Device

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  Class 3 Device Recall PerkinElmer 226 Sample Collection Device see related information
Date Initiated by Firm December 19, 2017
Create Date June 04, 2020
Recall Status1 Terminated 3 on March 26, 2021
Recall Number Z-2264-2020
Recall Event ID 85630
510(K)Number K121864  
Product Classification Newborn screening specimen collection paper - Product Code PJC
Product PerkinElmer 226 Sample Collection Device
Code Information UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700
Recalling Firm/
Manufacturer		 PerkinElmer Health Sciences, Inc.
17 P & N Drive
Greenville SC 29611
For Additional Information Contact
864-299-8787
Manufacturer Reason
for Recall		 PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
FDA Determined
Cause 2		 Packaging process control
Action PerkinElmer sent an Urgent Medical Device Correction letter dated 12/22/2017 by email to the sole consignee. PerkinElmer requested the consignee quarantine the product and contact Kerry Chunko, PerkinElmer Sr. Quality Manager for further information 864-299-8787. x 104 (Kerry.Chunko@PerkinElmer.com). The firm also requested the consignee inform all those affected by this issue in their organization and to return the recall response form and return it by fax to 864-299-8787 or as a scanned by email to Kerry.Chunko@PerkinElmer.com.
Quantity in Commerce 164,952 devices
Distribution US distribution in the state of Ohio
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.
510(K) Database 510(K)s with Product Code = PJC and Original Applicant = PERKINELMER, INC.
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