[pending] Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitativ
Pending LLM rewrite. Source: FDA_DEVICE Z-0501-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- TECHNO-PATH MANUFACTURING LTD.
- Category
- Medical Device — Devices
Distribution
Distributed in 17 states:
- CA
- CO
- CT
- FL
- HI
- IL
- LA
- MI
- MN
- NV
- NY
- OR
- SC
- TN
- TX
- WI
- WY
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