Z-2264-2020Class III

PerkinElmer 226 Sample Collection Device

Name: Z-2264-2020 PerkinElmer 226 Sample Collection Device
Creator: PerkinElmer Health Sciences, Inc.
Published: 2017-12-19
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2017-12-19 / Terminated / root cause: packaging

FDA source

PerkinElmer Health Sciences, Inc. began a recall of PerkinElmer 226 Sample Collection Device on 2017-12-19. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2264-2020
Classification: Class III
Status: Terminated
Initiated: 2017-12-19
Posted: 2020-06-04
Terminated: 2021-03-26
Recalling firm: Revvity Health Sciences, Inc.
Product: PerkinElmer 226 Sample Collection Device
Product code: PJC Newborn Screening Specimen Collection Paper
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.
Root cause tag: packaging
FDA root cause: 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 ([email protected]). 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 [email protected].
Quantity in commerce: 164,952 devices
Distribution: US distribution in the state of Ohio
Product codes and lots: UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2264-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2264-2020	Class III	Terminated	Voluntary: Firm initiated	2020-06-10	2020-06-04

Product code PJC

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)