Facility

STANBIO LABORATORY

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

Key facts

5recalls · 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)	1616487
Establishment type	Manufacture Medical Device
Location	1261 NORTH MAIN ST. Boerne, TX, US 78006
Registration status	Active · expires 2026
Parent company	STANBIO LABORATORY (owner-operator 1616487)

Activity by year

Recalls (5)
Inspections (1)

Devices registered here (1)

Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Product code CEO (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1580

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.

FDA inspections (1)

NAI2017-06-30
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.

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. “STANBIO LABORATORY (FEI 1616487) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1616487-stanbio-laboratory/

Not open yet

Alerts for STANBIO LABORATORY

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.