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Helix Elite™ Molecular Standards: Synthetic Standard
MICROBIOLOGICS INC. · Model HE0014S · UDI-DI 10845357041866
0
510(k) clearances
6
Adverse events
27
Recalls
57
Facilities
Description
Helix Elite™ Molecular Standards West Nile Virus Synthetic RNA
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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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.