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NATtrol™

ZEPTOMETRIX CORPORATION · Model NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae Negative Controls · UDI-DI 01220000260047

OHQ

510(k) clearances

Adverse events

Recalls

Facilities

Description

The NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ CT/NG Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures.

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.