Home › ZEPTOMETRIX CORPORATION › NATtrol™

NATtrol™

ZEPTOMETRIX CORPORATION · Model NATtrol™ Flu/RSV/SARS-CoV-2 Swab Control Kit · UDI-DI 01220000260634

510(k) clearances

Adverse events

Recalls

Facilities

Description

NATtrol™ Flu/RSV/SARS-CoV-2 Swab Control Kit NATFRC-SW-IVD) is a qualitative in vitro diagnostic external control kit containing positive and negative controls intended to evaluate test performance of molecular assays which detect Influenza A, Influenza B, RSV B and SARS-CoV-2 nucleic acids.

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.