Home › Device types › OHQ
Multi-Analyte Controls Unassayed
FDA product code OHQ · Class 1 · Clinical Chemistry
609
Registered devices
6
Adverse events
27
Recalls
0
510(k) clearances
Devices with this code
NATtrol™ — ZEPTOMETRIX CORPORATIONLiquichek — BIO-RAD LABORATORIES, INC.Fort Worth Diagnostics — Fort Worth Diagnostics, LLCNATtrol™ — ZEPTOMETRIX CORPORATIONExact Diagnostics — EXACT DIAGNOSTICS, LLCExact Diagnostics — EXACT DIAGNOSTICS, LLCSPOTCHECK — ASTORIA-PACIFIC, INC.Multichem S — TECHNO-PATH MANUFACTURING LIMITEDNATtrol™ — ZEPTOMETRIX CORPORATIONMultichem A1c — TECHNO-PATH MANUFACTURING LIMITEDTri-Valent™ Swab — MICROBIOLOGICS INC.VIROCLEAR — BIO-RAD LABORATORIES, INC.NATtrol™ — ZEPTOMETRIX CORPORATIONMultichem AE — TECHNO-PATH MANUFACTURING LIMITEDHelix Elite™ Molecular Standards: Inactivated Standard — MICROBIOLOGICS INC.NATtrol™ — ZEPTOMETRIX CORPORATIONMultichem AMH — TECHNO-PATH MANUFACTURING LIMITEDNATtrol™ — ZEPTOMETRIX CORPORATIONMultichem A1c — TECHNO-PATH MANUFACTURING LIMITEDHelix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS INC.Helix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS INC.SEROLOGY NEGATIVE CONTROL (SEROLOGY CONTROL -) — RANDOX LABORATORIES LIMITEDHelix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS INC.QC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.
Recent 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. Ad |
| 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. Ad |
| 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. Ad |
| 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 A549 human cell target (human cells for sample adequacy control) may give a late Ct value. |
| 2025-02-20 | Microbiologics Inc | The RSV target may give a late Ct value and could potentially not pass QC. |
| 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 tha |
| 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 tha |
| 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.