TECHNO-PATH MANUFACTURING LTD. is recalling 127 units of Multichem ID-B Positive Control (Model SR103B) because the HBsAg analyte may show negative recovery when used on Alinity i laboratory testing platforms. This product is used in laboratories as a quality control serum to ensure that tests for diseases such as HIV, Hepatitis B and C, and Syphilis are functioning accurately. If the control does not perform correctly, laboratory staff may not realize that their testing system is failing to detect the virus.
The defect may result in incorrect laboratory quality control measurements for Hepatitis B surface antigen (HBsAg). This poses a risk of clinicians relying on inaccurate laboratory data, potentially leading to missed diagnoses or incorrect patient management.
Includes Recall Numbers Z-0501-2026 (lot SB140524P) and Z-0502-2026 (lot SB161024P).
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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