FDA Medical Device Recalls (openFDA)
PerkinElmer Health Sciences, Inc.: PerkinElmer 226 Sample Collection Device
- Recall number
- Z-2264-2020
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Product
- PerkinElmer 226 Sample Collection Device
- Status
- Terminated
- Initiated
- 2017-12-19
- Posted
- not on file
- Terminated
- 2021-03-26
- Reason
- 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
- 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 (Kerry.Chunko@PerkinElmer.com). 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 Kerry.Chunko@PerkinElmer.com.
- Quantity
- 164,952 devices
- Distribution
- US distribution in the state of Ohio
- Lot, serial or model codes
- UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700
- 510(k) numbers
- ["K121864"]
- PMA numbers
- not on file
- Product code
- PJC
- Firm FEI
- 3007145015
- Firm city
- Greenville
- Firm state
- SC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28