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U.S. Department of Health and Human Services

Class 2 Device Recall PerkinElmer 226 Sample Collection Device

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 Class 2 Device Recall PerkinElmer 226 Sample Collection Devicesee related information
Date Initiated by FirmSeptember 05, 2013
Date PostedOctober 18, 2013
Recall Status1 Terminated 3 on July 17, 2014
Recall NumberZ-0030-2014
Recall Event ID 66310
510(K)NumberK121864 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductPerkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Code Information Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.
Recalling Firm/
Manufacturer		 Perkin Elmer Health Sciences, Inc.
17 P & N Drive
Greenville SC 29611
For Additional Information ContactRick Haines
864-299-8787 Ext. 104
Manufacturer Reason
for Recall		Some devices may be contaminated on the back side of the device with glue in the blood application area.
FDA Determined
Cause 2		Material/Component Contamination
ActionThe firm, Perkin Elmer, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated September 5, 2013 via email to its consignees. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately notify all submitting facilities and personnel that have received the PerkinElmer 226 Sample Collection Device of the potential glue contamination and to distribute the enclosed record of actions form to all submitting facilities/personnel and encourage them to perform the inspection activities as listed in the letter; and complete and return the enclosed Recall Response Form return it to PerkinElmer Health Sciences via fax to: 864-299-8797 or email to: Rick.Haines@perkinelmer.com. Please contact PerkinElmer Health Sciences Greenville facility Quality Manager for further information 864-299-8787 (ext 104).
Quantity in Commerce65,984 devices
DistributionUS distribution in OH
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JKA
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