Topic archive
MedTech Current publications and recall entries tagged IVD & Laboratory Diagnostics.
FDA has classified the recall of Nova Biomedical's StatStrip Glucose Hospital Meter Systems (Gen 2.0) as Class I because retained barcode information may assign glucose results to the wrong patient or quality-control identifier.
Five Chinese IVD guidance technical document projects cover POCT personnel, public health emergencies and CTC pre-examination processes. All remain at the drafting stage; the POCT project is intended to replace GB/Z 43281-2023.
China's 2026 HCV genotyping guidance replaces the earlier overall clinical sample-size wording with recommendations for individual genotypes and subtypes. Analytical coverage, comparator selection and labeling remain important to substantiating the claimed detection range.
China's 2026 HER2 gene amplification guidance replaces fixed clinical sample counts with a statistical estimation framework for positive and negative agreement. Separate designs for each indication, drug-linked comparators and borderline-sample evaluation remain central to the evidence package.
Norway proposes to incorporate EU rules on notified body quotations, assessment timelines and re-certification. Comments are due by 9 December 2026; Norwegian commencement remains to be determined, and EU transition rules depend on agreement and certificate expiry dates.
Mexico's updated blood standard requires HIV, HBV and HCV nucleic acid testing and extends irregular antibody screening to all donors. It provides 180 calendar days before entry into force and a further 180 days for the two testing requirements.
The Class II rule covers home specimen collection followed by clinical laboratory testing, not at-home result generation. Existing classification controls address the collection device, specimen-specific evidence, shipping integrity and user information.
The draft addresses manufacturing licence applications by domestic IVD manufacturers and invites comments within 15 days of publication. It should not be treated as effective guidance or a universal checklist for import projects.
An operational analyzer can produce results that mislead clinical interpretation. Beyond calibration and discarded tests, the Medical Director must decide whether earlier results need action. Laboratory and IVD quality teams face an assay correction and a review of its clinical implications.
NMPA is consulting on a pathway for eligible Class II and III devices with valid domestic registration certificates to be registered by a related applicant in another province. The draft would allow reuse of specified registration materials while retaining testing and quality-system requirements; comments are due October 30, 2026.
NMPA is consulting on an IVD reagent GMP inspection draft that integrates the general GMP and IVD appendix into 212 inspection items across three risk levels. Comments are due October 10, 2026; the same notice also covers a separate custom-made denture draft.
False-positive pregnancy results may affect subsequent clinical decisions. Because the affected tests appear under several brands, laboratories and distributors need to trace which configurations they supplied and ensure downstream users receive the correction notice.
MDCG 2020-16 rev.5 clarifies the classification rationale and practical examples for Rule 7 control materials under IVDR, establishing key distinctions between unassigned Class B controls and assay-specific materials.
This event directly connects assay precision to treatment decisions and makes prior-result review part of the field response.
The defect is notable because a software import can silently change laboratory calculation logic rather than producing an obvious system failure. Laboratories determine whether predefined rules were modified and whether results need retrospective review.
The Philippine FDA is consulting on a draft Administrative Order that would establish a more complete regulatory framework for medical device clinical investigations and IVD clinical performance studies, including sponsor and CRO licensing, ethics review, FDA study approvals, safety reporting, and inspections. The draft remains under consultation and may change before final issuance.
False-negative molecular respiratory results can directly affect diagnostic decision-making, making this recall particularly relevant to laboratories and IVD manufacturers. The failure also shows how a reagent-manufacturing error can escape normal controls while control assays still pass, creating a significant result-integrity and quality-system lesson.
This recall connects a manufacturing-process deviation directly to the reliability of a diagnostic result used in acute kidney injury assessment. It is relevant to IVD quality teams because the FDA record links the non-validated rework to potential downstream diagnostic, treatment, and monitoring consequences rather than a purely administrative nonconformity.