Revvity 226 Newborn Screening CardRecalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

2 other recalls cover devices cleared under the same FDA submission (K121864); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Dec 19, 2017Class IIITerminated
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.
Z-2264-2020 · Root cause: Packaging process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121864. One submission often covers many models, so check the product and lot details in each record.

Z-2756-2017 · May 31, 2017 · Terminated
PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a l
Z-0030-2014 · Sep 5, 2013 · Terminated
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 tr

Device details

UDI-DI	`50812589020011`
Brand	Revvity 226
Model	Newborn Screening Card
Company	Revvity, Inc.
Product code	PJC · Newborn Screening Specimen Collection Paper
Class	Class 2
FDA submission	K121864
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 5, 2024

Device type (GMDN): Dried blood spot collection card IVD

A device intended to be used for dried blood spot collection and preservation, at the point-of-care, for subsequent diagnostic testing or screening. It is typically in the form of paper integrated in a card, on which a whole blood specimen is applied and absorbed onto the collection paper. The card may include a form to capture patient demographic information This is a single-use device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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