Facility

CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

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

Key facts

3recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

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

FDA Establishment Identifier (FEI)	3003951180
Establishment type	Manufacture Medical Device
Location	Am Haag 12 Gräfelfing Bavaria, DE 82166
Registration status	Active · expires 2026
Parent company	CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH (owner-operator 9067715)
Brand names	Vitamins A & E by HPLC Test; HPLC Reagent Kit beta carotene in serum/plasma; UHPLC Reagent Kit One Step Vitamins A and E in serum/plasma; HPLC Reagent Kit Vitamins A and E in serum/plasma Automated with 96 Well Filter Plates; HPLC Reagent Kit One Step Vitamins And E in serum/plasma; HPLC Reagent Kit Vitamins A and E in serum/plasma; UHPLC Reagent Kit Vitamins A and E in serum/plasma Automated with 96 Well Filter Plates

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Acid, Trifluoroacetic, Vitamin A, Hexane Extraction
Product code JOA (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1805

Recalls & enforcement

Class IITerminated2022-05-19
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
Class IITerminated2020-11-02
XXX
Class IICompleted2020-10-29
Control lots may not meet stability criteria and could result in increased results of patient samples for cortisone.

FDA inspections (1)

NAI2016-06-23
No Action Indicated · Compliance: 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.

All facilities operated by CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH

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. “CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH (FEI 3003951180) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003951180-chromsystems-instruments-chemicals-gmbh/

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