FDA Device Recall Z-0030-2014: Perkin Elmer Health Sciences, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0030-2014.

Recall Res Number

Z-0030-2014

Recalling Firm / Manufacturer

Perkin Elmer Health Sciences, Inc.

FEI Number

3007145015

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2013-09-05

Date Posted

2013-10-18

Date Terminated

2014-07-17

Product Code

JKA

Event Number

66310

Product Quantity

65,984 devices

Product Description Perkin 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.

Reason for Recall Some devices may be contaminated on the back side of the device with glue in the blood application area.

Action Details The 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).

Distribution Pattern US distribution in OH

Code Information / Serial Numbers Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.

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Medical Device Recall: Z-0030-2014

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer