RegWardenFDA facility compliance records
Facility

ANSH LABS, LLC

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

Activity by year

FDA actions on record by year2020: 1 recalls, 1 inspections20172018201922020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Radioimmunoassay, Human Growth Hormone
    Product code CFL (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1370

Recalls & enforcement

  • Class IITerminated2020-12-18
    Labeling update; To reduce the risk of false positive/false negative results the IFU for the adaptive immune response to SRS-CoV-2 testing is being updated to remove Plasma as a "sample type" and to update the "limitation" section to include potential cross-reactivity with non-S…

FDA inspections (1)

  • VAI2020-02-10
    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.

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. “ANSH LABS, LLC (FEI 3008198807) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008198807-ansh-labs-llc/

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