The FDA has posted 6 enforcement recalls of multi-analyte controls unassayed devices since 2025, none of them Class I (most serious). Most recent report: Nov 19, 2025.
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.
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 RSV target may give a late Ct value and could potentially not pass QC.
The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded.…
Internal quality control procedures were not followed correctly for the testing/release of three lots of 8234/8235. This resulted in the release of products that should have failed and been discarded.…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Multi-Analyte Controls Unassayed”). Informational only — verify against the FDA before acting.