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Mimix™ Quantitative Multiplex FFPE reference standard

REVVITY DISCOVERY LIMITED · Model HD200-IVD · UDI-DI 05056850400038

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Mimix™ Quantitative Multiplex FFPE Reference Standard is a commutable control material comprising a formalin-fixed paraffin-embedded (FFPE) curl derived from human cancer cell lines. It is intended for quantitative and/or qualitative monitoring using droplet digital polymerase chain reaction (ddPCR) assays designed to detect somatic mutations in genomic DNA (gDNA) from human samples for in vitro diagnostic use. The gDNA obtained from Quantitative Multiplex FFPE Reference Standard can be used to monitor ddPCR workflow, test performance, assay variation and helps identify increases in random or systematic errors. This product is for professional laboratory use only.

Recalls

Date	Firm	Reason
2026-08-14	TECHNO-PATH MANUFACTURING LTD.	A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing con
2026-08-14	TECHNO-PATH MANUFACTURING LTD.	A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing con
2026-08-14	TECHNO-PATH MANUFACTURING LTD.	A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing con
2025-10-17	TECHNO-PATH MANUFACTURING LTD.	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.
2025-10-17	TECHNO-PATH MANUFACTURING LTD.	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.
2025-02-20	Microbiologics Inc	The RSV target may give a late Ct value and could potentially not pass QC.
2025-02-20	Microbiologics Inc	The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.
2025-01-20	Microbiologics Inc	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
2025-01-20	Microbiologics Inc	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
2024-01-08	Microbiologics Inc	The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the neg

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.