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Newborn Screening Specimen Collection Paper

FDA product code PJC · Class 2 · Clinical Chemistry

7
Registered devices
0
Adverse events
3
Recalls
2
510(k) clearances

Devices with this code

Revvity 226 — Revvity, Inc.Revvity 226 — Revvity, Inc.Revvity 226 — Revvity, Inc.903 DBS Collection Cards - 6 Samples — MONOBIND, INC.903 DBS Collection Cards - 5 Samples — MONOBIND, INC.Revvity 226 — Revvity, Inc.Revvity 226 — Revvity, Inc.

Recent recalls

DateFirmReason
2017-12-19PerkinElmer 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 de
2017-05-31PerkinElmer 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 devi
2015-06-17Agilent Technologies, Inc.The product was marketed without 510(k) clearance.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.