QC Sets and Panels: Helix Elite™
QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)
2manufacturers in China registered for this device type
51catalogue numbers in this listing
19recalls on this 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 | Microbiologics, Inc., United States |
|---|---|
| FDA product code | OHQ |
| Device type | Multi-Analyte Controls Unassayed |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-09-08 |
| Record revised | 2022-10-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
| Distribution end date | 2026-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8248 | In distribution | |
| 8249 | In distribution | |
| 8189 | In distribution | |
| 8187 | In distribution | |
| 8247 | In distribution | |
| 8238 | In distribution | |
| 8246 | In distribution | |
| 8205 | In distribution | |
| 8208 | In distribution | |
| 8206 | In distribution | |
| 8258 | In distribution | |
| 8269 | In distribution | |
| 8236 | In distribution | |
| 8210 | In distribution | |
| ABT-001 | In distribution | |
| 8231 | In distribution | |
| 8209 | In distribution | |
| 8268 | In distribution | |
| 8191 | In distribution | |
| 8232 | In distribution | |
| 8245 | In distribution | |
| 8234 | In distribution | |
| 8227 | In distribution | |
| 8246-SPL | In distribution | |
| 8230 | In distribution | |
| 8184 | In distribution | |
| 8219 | In distribution | |
| 8228 | In distribution | |
| 8235 | In distribution | |
| 8255 | In distribution | |
| 8211 | In distribution | |
| 8181 | In distribution | |
| 8250 | In distribution | |
| 8267 | In distribution | |
| 8180 | In distribution | |
| 8203 | In distribution | |
| 8229 | In distribution | |
| 8254 | In distribution | |
| 8242 | In distribution | |
| 8198 | Withdrawn | |
| 8190 | Withdrawn | |
| 8240 | Withdrawn | |
| 8214 | Withdrawn | |
| 8217 | Withdrawn | |
| 8215 | Withdrawn | |
| 8233 | Withdrawn | |
| 8182 | Withdrawn | |
| CL00016 | Withdrawn | |
| 8216 | Withdrawn | |
| 8201 | Withdrawn | |
| 8244 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exact Diagnostics | Exact Diagnostics | 64 |
| NATtrol™ | Zeptometrix LLC. | 54 |
| 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 |
| Multichem IA Plus | Techno-Path Manufacturing Ltd. | 17 |
| 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
5 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Microbiologics, Inc. | UDI-DI | 2025-01-20 | Class II | Under Investigation by firm | 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 and been discarded. The concentration of one target (HPV 16 | 16 units | |
| Microbiologics, Inc. | UDI-DI | 2025-01-20 | Class II | Under Investigation by firm | 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 and been discarded. The concentration of one target (HPV 16 | 27 units | |
| Microbiologics, Inc. | UDI-DI | 2024-01-08 | Class II | Process control | 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 negative control. | 580 packages | |
| Microbiologics, Inc. | UDI-DI | 2022-03-03 | Class II | Incorrect or no expiration date | Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. | 13 units | 2024-01-16 |
| Microbiologics, Inc. | UDI-DI | 2022-02-25 | Class II | Nonconforming Material/Component | Distributed product did not undergo proper release testing. | 80 units | 2024-01-16 |
Recalls
13 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-02-20 | Class II | Nonconforming Material/Component | The RSV target may give a late Ct value and could potentially not pass QC. | 28 units | |
| 2025-02-20 | Class II | Process control | The A549 human cell target (human cells for sample adequacy control) may give a late Ct value. | 6 units | |
| 2022-07-27 | Class III | Process control | Product not registered for use in the UK | 2 | 2024-08-02 |
| 2022-03-24 | Class II | Process control | QC process was not adequate for the specification range. | 1 ea | 2023-01-09 |
| 2022-03-22 | Class II | Process control | The QC process was not adequate for the specification range. | 2 ea | 2023-01-09 |
| 2021-08-20 | Class II | Material/Component Contamination | The product indicated is contaminated with a plasmid DNA that contains the target SARS-CoV-2 sequences. | 127 | 2023-01-12 |
| 2021-08-20 | Class II | Material/Component Contamination | The SARS-CoV-2 Process Control (Pellet) contains RNA transcripts that include diagnostically relevant SARS-CoV-2 targets (CDC and WHO consensus sequences). | 218 | 2023-01-12 |
| 2020-01-03 | Class II | Process control | Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient te | 9 | 2020-09-16 |
| 2019-12-16 | Class II | Device Design | The recommended hydration fluid for the 8180 Gram-Positive Blood Culture Control Panel (Inactivated Pellet), has changed from sterile 0.85% saline or sterile blood culture media to sterile DI water or pH 7.2 phosphate buffer. | 810 | 2020-12-11 |
| 2017-06-06 | Class II | Process design | Real-time shelf life testing failed at 24 months | 1 | 2023-01-17 |
| 2017-06-06 | Class II | Process design | Real-time shelf life testing failed at 24 months | 29 units | 2023-01-17 |
| 2017-06-06 | Class II | Process design | Real-time shelf life testing failed at 24 months | 1 unit | 2023-01-17 |
| 2017-06-06 | Class II | Process design | Real-time shelf life testing failed at 24 months | 1 unit | 2023-01-17 |
| 2017-06-06 | Class II | Process design | Real-time shelf life testing failed at 24 months | 8 units | 2023-01-17 |
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.