Home › Revvity, Inc. › Revvity 226
Revvity 226
Revvity, Inc. · Model Newborn Screening Card · UDI-DI 50812589020011
PJC
Prescription
1
510(k) clearances
0
Adverse events
3
Recalls
2
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-19 | PerkinElmer Health Sciences, Inc. | 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 with |
| 2017-05-31 | PerkinElmer Health Sciences, Inc. | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within |
| 2015-06-17 | Agilent Technologies, Inc. | The product was marketed without 510(k) clearance. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.