Z-0030-2014Class II

Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample...

Name: Z-0030-2014 Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample...
Creator: Perkin Elmer Health Sciences, Inc.
Published: 2013-09-05
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2013-09-05 / Terminated / root cause: manufacturing process

FDA source

Perkin Elmer Health Sciences, Inc. began a recall of Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a... on 2013-09-05. FDA classified it as Class II and gives the reason as "Some devices may be contaminated on the back side of the device with glue in the blood application area". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0030-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-05
Posted: 2013-10-18
Terminated: 2014-07-17
Recalling firm: Revvity Health Sciences, Inc.
Product: 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.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Some devices may be contaminated on the back side of the device with glue in the blood application area.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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: [email protected]. Please contact PerkinElmer Health Sciences Greenville facility Quality Manager for further information 864-299-8787 (ext 104).
Quantity in commerce: 65,984 devices
Distribution: US distribution in OH
Product codes and lots: Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0030-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0030-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-18

Product code JKA

K121864Class IIPerkinelmer 226 Sample Collection DevicesPerkinelmer, Inc. / cleared 2013-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)