Facility

PHADIA GMBH

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

Key facts

5recalls · worst Class II

—inspections in our data

—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)	3005774014
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	MUNZINGER STRASSE 7 FREIBURG Baden-Wurttemberg, DE 79111
Registration status	Active · expires 2026
Parent company	PHADIA AB (owner-operator 9004441)
Brand names	EliA Stool Extraction Buffer plus

Activity by year

Recalls (5)

Devices registered here (1)

Agent, Clearing
Product code KEM (opens in a new tab) · Class I · Pathology · 21 CFR 864.4010

Recalls & enforcement

Class IIOngoing2023-05-24
Complaints that specific samples produced false positive EliA GBM results. A positive signal was present when these samples were tested for coating-solution reactivity using EliA wells without antigen.
Class IITerminated2019-07-09
code 7-102 Liquid Sensor Error
Class IITerminated2019-05-10
Potential for reporting low assay results
Class IITerminated2017-11-20
We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including 2.1.4, when rejecting and retesting samples with any EliA assay (the OK function may be used for rejecting single tes…
Class IITerminated2015-12-28
All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals ar…

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. “PHADIA GMBH (FEI 3005774014) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005774014-phadia-gmbh/

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