RegWardenFDA facility compliance records
Facility

MACHEREY-NAGEL GMBH & CO., KG.

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

Activity by year

FDA actions on record by year2024: 1 recalls, 1 inspections20172018201920202021202220232202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Tubeless Analysis, Gastric Acidity
    Product code JLL (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1320

Recalls & enforcement

  • Class IIOngoing2024-04-04
    The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on some of the test strips. The issue was identified by a consumer by way of a Henry Schein Inc. (HSI) customer complaint. This problem can potentially result in the possibility that the…

FDA inspections (1)

  • NAI2024-06-06
    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. “MACHEREY-NAGEL GMBH & CO., KG. (FEI 4580) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/4580-macherey-nagel-gmbh-co-kg/

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