Home › Device types › OHQ
Multi-Analyte Controls Unassayed
FDA product code OHQ · Class 1 · Clinical Chemistry
603
Registered devices
6
Adverse events
24
Recalls
0
510(k) clearances
Devices with this code
Multichem SP — TECHNO-PATH MANUFACTURING LIMITEDMultichem S — TECHNO-PATH MANUFACTURING LIMITEDExact Diagnostics — EXACT DIAGNOSTICS, LLCMultichem S Plus — TECHNO-PATH MANUFACTURING LIMITEDCueSee VeriSTAT® — Eurotrol B.V.Helix Elite™ Molecular Standards: Inactivated Standard — MICROBIOLOGICS INC.NATtrol™ — ZEPTOMETRIX CORPORATIOND3 — DIAGNOSTIC HYBRIDS, INC.Helix Elite™ Molecular Standards: Inactivated Standard — MICROBIOLOGICS INC.QC Sets and Panels: KWIK-STIK™ — MICROBIOLOGICS INC.NATtrol™ — ZEPTOMETRIX CORPORATIONMultichem S Plus — TECHNO-PATH MANUFACTURING LIMITEDMultichem A1c — TECHNO-PATH MANUFACTURING LIMITEDQC Sets and Panels: KWIK-STIK™ — MICROBIOLOGICS INC.Multichem P — TECHNO-PATH MANUFACTURING LIMITEDMultichem AE — TECHNO-PATH MANUFACTURING LIMITEDNATtrol™ — ZEPTOMETRIX CORPORATIONFort Worth Diagnostics — Fort Worth Diagnostics, LLCQC Sets and Panels: Helix Elite™ — MICROBIOLOGICS INC.Helix Elite™ Molecular Standards: Synthetic Standard — MICROBIOLOGICS INC.ExpertCor Routine — DSRV IncHelix Elite™ Molecular Standards: Inactivated Standard — MICROBIOLOGICS INC.NATtrol™ — ZEPTOMETRIX CORPORATIONMultichem U — TECHNO-PATH MANUFACTURING LIMITED
Recent 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 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 |
| 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 n |
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