Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control se
Summary
The FDA issued a Class II for Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed by TECHNO-PATH MANUFACTURING LTD.. Reason: 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..
Details
Source
Device Recall
External ID
Z-0501-2026
Action Date
2025-11-19
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026
Quantity Affected: 76 units
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.
Distribution
US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-17
Company
Ballina Tipperary
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TECHNO-PATH MANUFACTURING LTD. has 6 FDA actions in our database, including 5 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TECHNO-PATH MANUFACTURING LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TECHNO-PATH MANUFACTURING LTD. have FDA actions?
TECHNO-PATH MANUFACTURING LTD. has 6 FDA actions in our database, including 5 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0501-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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