Z-0501-2026Class II

Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality...

Name: Z-0501-2026 Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality...
Creator: Techno-Path Manufacturing Ltd.
Published: 2025-10-17
License: https://open.fda.gov/license/

Techno-Path Manufacturing Ltd. / initiated 2025-10-17 / Open, Classified / root cause: manufacturing process

FDA source

TECHNO-PATH MANUFACTURING LTD. began a recall of Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory... on 2025-10-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0501-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-17
Posted: 2025-11-14
Recalling firm: Techno-Path Manufacturing Ltd.
Product: Multichem ID-B. Model/Catalog 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.
Product code: OHQ Multi-Analyte Controls Unassayed
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: LGC Clinical Diagnostics notified consignees on about 10/17/2025 via letter that Techno-path Manufacturing Ltd was recalling specific Multichem ID-B products. Consignee were informed that the Instructions for Use (IFU) for Multichem ID-B SR103B, Lots SB140524P and SB161024P have been updated to remove the representative reactivity for the analyte HBsAg; therefore, no representative reactivity result will be provided for HBsAg in these lots. Consignees were instructed to discard all previous versions of the IFU for affected lots, share the information with all applicable laboratory staff or customers if further distributed, retain the notification as part of the laboratory Quality System documentation, and complete and return the provided response form. Techno-path Manufacturing Ltd. is investigating this issue and will implement a correction for all future lots of Multichem ID-B Positive Control SR103B that will be released.
Quantity in commerce: 76 units
Distribution: US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Product codes and lots: Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0501-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0501-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13
Z-0502-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)