Facility

EKF Life Sciences

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)	3017101757
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	6879 Enterprise Drive South Bend, IN, US 46628
Registration status	Active · expires 2026
Parent company	STANBIO LABORATORY (owner-operator 1616487)

Activity by year

Recalls (5)

Devices registered here (1)

Microbial Nucleic Acid Storage And Stabilization Device
Product code QBD (opens in a new tab) · Class II · Microbiology · 21 CFR 866.2950

Recalls & enforcement

Class IIOngoing2023-10-02
Deterioration in the stability of the Test Strips results in diminished low-range detection capability and inability to meet linearity performance claims. The root cause of the stability deterioration in is identified as the change in material that caused a pH shift in the coatin…
Class IITerminated2022-03-16
The device was being marketed as an IVD without a 510(k). Therefore, performance characteristics of these breast milk analyzers have not been adequately validated. An erroneous result could lead to sub-optimal nutrition supplementation for patients (infants)
Class IIITerminated2021-07-12
Deterioration in the stability of the reagents which has resulted in lower than expected or out of range Quality Control values.
Class IITerminated2018-02-13
All patient serum samples yield a weakly positive test result.
Class IITerminated2018-02-08
The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.

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. “EKF Life Sciences (FEI 3017101757) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017101757-ekf-life-sciences/

Not open yet

Alerts for EKF Life Sciences

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.