CLASS II ONGOING Device recall · Reported 19 Nov 2025 · FDA Enforcement Report

Multichem ID recalled by Techno-path Manufacturing

Techno-path Manufacturing is recalling Multichem ID-B, distributed in 17 states. The recall was initiated on 17 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)261031(10) SB161024P. Lot Number: SB161024P. Expiration Date: 31-10-2026.

Quantity recalled51 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0502-2026
FDA event ID: 97800
Recalling firm: Techno-path Manufacturing, Ballina Tipperary
Classification: Class II
Status: Ongoing
Recall initiated: 17 Oct 2025
FDA classified: 13 Nov 2025
Reported: 19 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Potency & Assay
Device type: Patient Monitors

Timeline

17 Oct 2025	Recall initiated by company
13 Nov 2025	Classified by FDA	+27 days
19 Nov 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination of anti-HIV-1 IgG, anti-HBc IgG, anti-HTLV-I IgG, anti-HCV IgG, HBs antigen and anti-Treponema pallidum IgG.

Where it was distributed

US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.

California Colorado Connecticut Florida Hawaii Illinois Louisiana Michigan Minnesota Nevada New York Oregon South Carolina Tennessee Texas Wisconsin Wyoming

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)261031(10) SB161024P. Lot Number: SB161024P. Expiration Date: 31-10-2026.

Where was it sold?

US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97800

This product is part of a recall event; the main page for the event is Multichem ID recalled by Techno-path Manufacturing.

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025	CLASS II	Multichem ID recalled by Techno-path Manufacturing	Techno-path Manufacturing	Potency & Assay	17 states

More recalls from Techno-path Manufacturing

All 5

Reported	Class	Recall	Company	Reason	Where
19 Nov 2025Device	CLASS II	Multichem ID recalled by Techno-path Manufacturing	Techno-path Manufacturing	Potency & Assay	17 states
18 Oct 2023Device	CLASS II	Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86 recalled	Techno-path Manufacturing	Foreign Material	Nationwide
18 Oct 2023Device	CLASS II	Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88 recalled	Techno-path Manufacturing	Foreign Material	Nationwide
18 Oct 2023Device	CLASS II	Multichem P, Part recalled by Techno-path Manufacturing	Techno-path Manufacturing	Foreign Material	Nationwide

Other Patient Monitors recalls

All 1,022

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS III	Passport Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	T1 Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	cPM Series Patient Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	BeneVision Series Telemetry Monitor recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS III	Panorama and Telemetry Monitoring System recalled by Mindray DS USA	Mindray DS USA	Device Malfunction	Nationwide