PerkinElmer 226 Sample Collection Device recallZ-2264-2020 · PerkinElmer Health Sciences, Inc. · initiated Dec 19, 2017
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from PerkinElmer Health Sciences, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Packaging process control
What the company is doing
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].
Recall details
- Recall number
- Z-2264-2020
- Status
- Terminated
- Initiated by the company
- Dec 19, 2017
- Recalling firm
- PerkinElmer Health Sciences, Inc.
- Quantity
- 164,952 devices
- Product code
- PJC
- FDA submissions
- K121864
- Distribution
- US distribution in the state of Ohio
Product description
PerkinElmer 226 Sample Collection Device
Code information (models, lots, serial numbers)
UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Revvity 226 Newborn Screening CardRevvity, Inc. · Newborn Screening Specimen Collection Paper1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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