Alere™ I Influenza a & B Control Swab Kit
Control Swabs intended for use only with the Alere i Inuenza A & B product.
1manufacturer
1catalogue number
5510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | Alere Scarborough, Inc., United States |
|---|---|
| FDA product code | OCC |
| Device type | Respiratory Virus Panel Nucleic Acid Assay System |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3980 |
| 510(k) | K141520 |
| Record published | 2016-09-03 |
| Record revised | 2023-09-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2020-09-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 425-080 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Panther Fusion® | Hologic, Inc. | 4 |
| Prodesse | Hologic, Inc. | 4 |
| Solana | Diagnostic Hybrids, Inc. | 2 |
| Silaris RSV Supplemental Pack | Mesa Biotech, Inc. | 1 |
| Alere i RSV Control Swab Kit | Alere Scarborough, Inc. | 1 |
| ID NOW Influenza A & B 2 Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Xpert Xpress Flu/RSV | Cepheid | 1 |
| ID NOW Influenza A & B Control Swab Kit | Alere Scarborough, Inc. | 1 |
| Simplexa™ Flu A/B & RSV Direct | DiaSorin Molecular LLC | 1 |
| Alere™ i Influenza A & B | Alere Scarborough, Inc. | 1 |
| Respiratory Virus Plus (RV+) Amplification Tray | Nanosphere, Inc. | 1 |
| Accula Flu A / B Test | Mesa Biotech, Inc. | 1 |
Showing 12 of 39. All products under Respiratory Virus Panel Nucleic Acid Assay System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173932 | 2018-01-26 |
| K171792 | 2017-09-29 |
| K163266 | 2016-12-21 |
| K161375 | 2016-08-18 |
| K151464 | 2015-07-28 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Quidel Corp. | 510(k) number | 2017-01-25 | Class II | Mixed-up of materials/components | Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs. | 1,010 packages | 2017-06-02 |
| Abbott Diagnostics Scarborough, Inc. | 510(k) number | 2015-06-26 | Class II | Process change control | Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit | 257 Kits | 2015-09-15 |
| Abbott Diagnostics Scarborough, Inc. | 510(k) number | 2015-04-22 | Class II | Under Investigation by firm | High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit. | 213 kits plus 3 – evaluation use only kits | 2016-01-14 |
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.