RegWardenFDA facility compliance records
Facility

CellEra, LLC

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 1 recalls; 2019: 1 inspections; 2021: 1 recalls, 1 inspections, 1 warning letters; 2022: 1 inspections120162017201812019202032021120222023202420252026
  • Recalls (2)
  • Inspections (3)
  • Warning letters (1)

Devices registered here (2)

  • Glucose Dehydrogenase, Glucose
    Product code LFR (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345
  • System, Test, Blood Glucose, Over The Counter
    Product code NBW (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1345

Recalls & enforcement

  • Class IIITerminated2021-12-15
    Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the correct version of the IFU.
  • Class IITerminated2016-09-01
    Adhesive border was not sticky enough.

FDA inspections (3)

  • VAI2022-04-14
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • OAI2021-07-08
    Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2019-05-30
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CellEra, LLC (FEI 3007594734) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007594734-cellera-llc/

Not open yet

Alerts for CellEra, LLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.