Facility

DRG INSTRUMENTS GMBH

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

Key facts

1recalls · worst Class II

2inspections · worst OAI

2warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002800697
Establishment type	Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	FRAUENBERGSTRASSE 18 MARBURG Hesse, DE 35039
Registration status	Active · expires 2026
Parent company	BIOCHECK, INC. (owner-operator 9033543)
Brand names	Cardiolipin IgG ELISA

Activity by year

Recalls (1)
Inspections (2)
Warning letters (2)

Devices registered here (1)

System, Test, Anticardiolipin Immunological
Product code MID (opens in a new tab) · Class II · Immunology · 21 CFR 866.5660

Recalls & enforcement

Class IITerminated2021-10-14
Immunoassay TEST Kit do not meet product shelf-life standards resulting in failed controls.

FDA inspections (2)

OAI2024-11-07
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
OAI2016-10-28
Official 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 (2)

Warning Letter2025-03-31
Warning Letter (opens in a new tab) · Marburg
Warning Letter2017-09-27
Warning Letter (opens in a new tab) · Marburg

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.

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. “DRG INSTRUMENTS GMBH (FEI 3002800697) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002800697-drg-instruments-gmbh/

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