Multichem IA Plus
17 catalogue numbers from IA311X, listed by Techno-Path Manufacturing Ltd., Ireland, under Multi-Analyte Controls Unassayed. 2 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
Record
| Listed by | Techno-Path Manufacturing Ltd., Ireland |
|---|---|
| FDA product code | OHQ |
| Device type | Multi-Analyte Controls Unassayed |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-09-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IA311X | In distribution | |
| IA310MX | In distribution | |
| IA316X | In distribution | |
| 08P86-10 | In distribution | |
| IA318X | In distribution | |
| IA314X | In distribution | |
| 05P76-10 | In distribution | |
| IA315X | In distribution | |
| IA312X | In distribution | |
| IA310X | In distribution | |
| IA313A | In distribution | |
| IA310A | In distribution | |
| IA312A | In distribution | |
| IA313X | In distribution | |
| IA315MX | In distribution | |
| IA311A | In distribution | |
| IA317X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exact Diagnostics | Exact Diagnostics | 64 |
| NATtrol™ | Zeptometrix LLC. | 54 |
| QC Sets and Panels: Helix Elite™ | Microbiologics, Inc. | 51 |
| Helix Elite™ Molecular Standards: Inactivated Standard | Microbiologics, Inc. | 41 |
| Multichem S Plus | Techno-Path Manufacturing Ltd. | 35 |
| Virotrol | Bio-Rad Laboratories Inc. | 27 |
| Helix Elite™ Molecular Standards: Synthetic Standard | Microbiologics, Inc. | 25 |
| D3 | Diagnostic Hybrids, Inc. | 14 |
| Liquichek | Bio-Rad Laboratories Inc. | 10 |
| Multichem IA | Techno-Path Manufacturing Ltd. | 8 |
| QC Sets and Panels: Kwik-Stik™ 2 Pack | Microbiologics, Inc. | 8 |
| QC Sets and Panels: Kwik-Stik™ | Microbiologics, Inc. | 7 |
Showing 12 of 107. All products under Multi-Analyte Controls Unassayed
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Techno-Path Manufacturing Ltd. | UDI-DI | 2023-08-25 | Class II | Unknown/Undetermined by firm | Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers ha | 41455 units |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-10-17 | Class II | Process control | 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. | 76 units |
| 2025-10-17 | Class II | Process control | 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. | 51 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.