Device recall: Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum
FDA enforcement event 97800 is a device recall by TECHNO-PATH MANUFACTURING LTD. of Ballina Tipperary, initiated 17 Oct 2025 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. TECHNO-PATH MANUFACTURING LTD. has 2 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
TECHNO-PATH MANUFACTURING LTD., Ballina Tipperary, Ireland.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0501-2026 | 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. | 76 units | Class II | Ongoing | 19 Nov 2025 |
| Z-0502-2026 | 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. | 51 units | Class II | Ongoing | 19 Nov 2025 |
Context
Other enforcement events for TECHNO-PATH MANUFACTURING LTD.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 25 Aug 2023 | Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 | Device | Class II | 3 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.