Siemens recalls specified EMIT 2000 Quinidine Assay lots over elevated-result risk
This event directly connects assay precision to treatment decisions and makes prior-result review part of the field response.
Topic archive
In Vitro Diagnostics
MedTech Current publications and recall entries tagged In Vitro Diagnostics.
Beckman Coulter recalls DxC 500 analyzers over calculated-rule software defect
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.
BioFire recalls specified BIOFIRE RP2.1 lot after false-negative results
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.
BioPorto recalls ProNephro AKI reagent kits after non-validated reagent rework
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.