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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 May 31, 2017
Date Posted July 24, 2017
Recall Status1 Terminated 3 on July 27, 2017
Recall Number Z-2756-2017
Recall Event ID 77668
510(K)Number K121864  
Product Classification Newborn screening specimen collection paper - Product Code PJC
Product PerkinElmer 226 Sample Collection Device

The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
Code Information lot numbers 317113 and 317114
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 317114 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
Action PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.
Quantity in Commerce 99,968 units
Distribution US Distribution to the state of : AL
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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