RegWardenFDA facility compliance records
Facility

BIOCHEMICAL DIAGNOSTICS, INC.

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

Activity by year

FDA actions on record by year2015: 1 recalls; 2021: 1 inspections12015201620172018201920201202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Drug Mixture Control Materials
    Product code DIF (opens in a new tab) · Class I · Clinical Toxicology · 21 CFR 862.3280

Recalls & enforcement

  • Class IIITerminated2015-09-14
    CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.

FDA inspections (1)

  • NAI2021-03-04
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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. “BIOCHEMICAL DIAGNOSTICS, INC. (FEI 2432495) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2432495-biochemical-diagnostics-inc/

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