Facility

TECHNO-PATH MANUFACTURING LTD.

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

Key facts

2recalls · 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)	3008156187
Establishment type	Export Device to the United States But Perform No Other Operation on Device; Manufacture Medical Device
Location	Fort Henry Business Park Ballina Tipperary, IE V94 FF1P
Registration status	Active · expires 2026
Parent company	Techno-path Manufacturing Ltd. (owner-operator 10030933)
Brand names	Multichem IA Plus, IA310A, IA311A, IA312A, IA313A,; Multichem IA Plus 05P76-10

Activity by year

Recalls (2)

Devices registered here (1)

Multi-Analyte Controls, All Kinds (Assayed)
Product code JJY (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1660

Recalls & enforcement

Class IIOngoing2025-10-17
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
Class IIOngoing2023-08-25
Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receivi…

All facilities operated by Techno-path Manufacturing Ltd.

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. “TECHNO-PATH MANUFACTURING LTD. (FEI 3008156187) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008156187-techno-path-manufacturing-ltd/

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