Facility

Trinity Biotech (Primus Corporation dba Trinity Biotech)

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

Key facts

1recalls · worst Class II

4inspections · worst OAI

1warning letters

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

FDA Establishment Identifier (FEI)	1931251
Establishment type	Manufacture Medical Device
Location	4231 E 75th Ter KANSAS CITY, MO, US 64132
Registration status	Active · expires 2026
Parent company	TRINITY BIOTECH, PLC (owner-operator 9025161)
Brand names	Premier Hb9210 HbA1c Assay Components; A. Menarini Premier Hb9210 Assay Components

Activity by year

Recalls (1)
Inspections (4)
Warning letters (1)

Devices registered here (1)

Assay, Glycosylated Hemoglobin
Product code LCP (opens in a new tab) · Class II · Hematology · 21 CFR 864.7470

Recalls & enforcement

Class IIOngoing2025-07-22
Potential for Bartels ELISA Legionella Urinary Antigen kit B1029-440 lot 065 and 066 to contain particulate matter.

FDA inspections (4)

NAI2022-09-26
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2021-09-17
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
OAI2020-02-06
Official Action Indicated · Compliance: Devices · citations posted
OAI2018-09-06
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 (1)

Warning Letter2020-08-12
Warning Letter (opens in a new tab) · Kansas City Missouri

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. “Trinity Biotech (Primus Corporation dba Trinity Biotech) (FEI 1931251) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1931251-trinity-biotech-primus-corporation-dba-t/

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