TECHNO-PATH MANUFACTURING LTD.: Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the p
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- 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.
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US distribution to CA, CO, CT, FL, HI, IL, LA, MI, MN, NV, NY, OR, SC, TN, TX, WI, WY.
- Recall initiated
- 2025-10-17
- Code info
- Model Number: SR103B. UDI: (01)05391523442312(240)SR103B(17)260531(10)SB140524P. Lot number: SB140524P. Expiration Date: 31-5-2026
- Product quantity
- 76 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Ballina Tipperary
- Country
- Ireland
- Event id
- 97800
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