NATtrol™
ZEPTOMETRIX CORPORATION · Model NATtrol™ RP Multimarker Controls · UDI-DI 01220000260016
Description
NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. 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 error. NATtrol™ RP Multimarker Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens. NATtrol™ RP Multimarker Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 3 x 0.75 mL vials of RP Multimarker 1 and 3 x 0.75 mL vials of RP Multimarker 2. NATtrol™ RP Multimarker Controls are formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.
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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