NATtrol™
ZEPTOMETRIX CORPORATION · Model NATtrol™ GI Controls · UDI-DI 01220000260481
Description
NATtrol™ GI Controls (NATGIC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus Type 41, C. difficile, C. parvum, E. coli (92.0147; EAEC1), E. coli (EDL933; O157), P. shigelloides, Rotavirus,S. sonnei, Sapovirus ( S. cerevisiae recombinant), V. cholera non-toxigenic, Y. enterocolitica, Astrovirus (S. cerevisiae recombinant),C. cayetanensis (S. cerevisiae recombinant), C. coli, C. jejuni, E. coli (7.1493; O84:H28; EPEC1),E. coli (ETEC; ST+, LT+), E. histolytica,G. lamblia,Norovirus GI (recombinant), Norovirus GII (recombinant),S. enterica typhimurium.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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 |
| 2023-11-06 | Randox Laboratories Ltd. | A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL. |
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2022-08-01 | Randox Laboratories Ltd. | ***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactiv |
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