COBAS®TaqMan® 48 Analyzer
Catalogue number 03279332001, listed by Roche Molecular Systems, Inc., United States, under Analyzer, Chemistry, Micro, For Clinical Use. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (1), Hubei (1), Henan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Autobio Labtec Instruments Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
Record
| Listed by | Roche Molecular Systems, Inc., United States |
|---|---|
| FDA product code | JJF |
| Device type | Analyzer, Chemistry, Micro, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2170 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2014-09-17 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03279332001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Diamedix | Diamedix Corp. | 2 |
| Spotcheck | Astoria-Pacific, Inc. | 2 |
| Cholestech LDX™ | Alere San Diego, Inc. | 2 |
| AWS | Randox Laboratories Limited | 1 |
| Liaison® XL | Diasorin Inc. | 1 |
| Soln Wash | Randox Laboratories Limited | 1 |
| Wash conc. 1 | Randox Laboratories Limited | 1 |
| NS | Randox Laboratories Limited | 1 |
| Liaison® Easy Starter Kit | Diasorin S.P.A | 1 |
| Rabs | Randox Laboratories Limited | 1 |
| Cl Soln | Randox Laboratories Limited | 1 |
| Wash Concentrate 2 | Medtest DX | 1 |
Showing 12 of 26. All products under Analyzer, Chemistry, Micro, For Clinical Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K012966 | 2002-02-01 |
| K964506 | 1997-05-21 |
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2012-02-01 | Class II | Nonconforming Material/Component | Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12×24 S-tube and 12×24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube tog | 2,132 boxes | 2013-07-16 |
| 2007-05-21 | Not classified | Other | For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions | 5,806 total | 2010-02-18 |
| 2004-05-24 | Not classified | Other | Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch. | 34 | 2006-03-08 |
| 2004-05-24 | Not classified | Other | Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch. | 75 | 2006-03-08 |
| 2003-03-06 | Not classified | Other | A false positive result may be reported. | 16 | 2003-12-10 |
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.