VP2000
Abbott VP2000 Processor Operations Manual, Rev. D
1manufacturer
10catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Hubei.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
Record
| Listed by | Abbott Molecular, Inc., United States |
|---|---|
| FDA product code | KEY |
| Device type | Stainer, Tissue, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3800 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-01 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02J11-065 | In distribution | |
| 02J11-041 | In distribution | |
| 02J11-042 | In distribution | |
| 02J11-062 | In distribution | |
| 02J11-056 | In distribution | |
| 02J11-001 | In distribution | |
| 02J11-061 | In distribution | |
| 03N27-51 | In distribution | |
| 02J11-057 | In distribution | |
| 02J11-063 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 2 |
| i6000™ Infinity | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Infinity | Biogenex Laboratories Inc. | 1 |
| NanoVIP® | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Elite | Biogenex Laboratories Inc. | 1 |
| i6000™ Diagnostics | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Nano | Biogenex Laboratories Inc. | 1 |
| Xmatrx® Mini | Biogenex Laboratories Inc. | 1 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-09-15 | Not classified | Device Design | Thermal runaway conditions, in that the target temperature was exceeded and the temperature display could not track the actual temperature within the heated slide basins of the VP 2000 Slide Processor. | 261 units | 2010-01-07 |
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.