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NATtrol™
ZEPTOMETRIX CORPORATION · Model NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control Swabs · UDI-DI 01220000260511
0
510(k) clearances
6
Adverse events
24
Recalls
57
Facilities
Description
NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control Swabs (NATFRCNEG-SW-IVD) is a qualitative in vitro diagnostic external control 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 |
|---|---|---|
| 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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Get your free API keyRead the docsData 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.