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NATtrol™
ZEPTOMETRIX CORPORATION · Model NATtrol™ Vaginal Bundle · UDI-DI 01220000260313
0
510(k) clearances
6
Adverse events
24
Recalls
57
Facilities
Description
NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) DI number 01220000260290, and NATtrol Vaginal Negative Control (NATVNEG-6C) DI number 01220000260306, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance.
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.