HistoCore Pearl
The HistoCore PEARL is designed to enable tissue processing, performing all steps from fixation to wax infiltration. It is normally processed in sequential mode, which means that the…
The HistoCore PEARL is designed to enable tissue processing, performing all steps from fixation to wax infiltration. It is normally processed in sequential mode, which means that the instrument is strictly using one bottle after the other. The HistoCore PEARL is a tissue processor for the following laboratory applications: Fixation Dehydration Infiltration with intermedium Paraffin infiltration of histological tissue specimens. The HistoCore PEARL must be operated exclusively with the reagents listed in the section of Compatible reagents
Who Else Makes It
Concentrated in Guangdong (2), Hunan (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Leica Instruments (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 11 |
| Dakewe(Shenzhen) Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 9 |
| Hangzhou Healthsky Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
Record
| Listed by | Leica Biosystems Nussloch Gmbh, Germany |
|---|---|
| FDA product code | IEO |
| Device type | Processor, Tissue, Automated |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3875 |
| Establishment | Private-label distributor, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-04 |
| Record revised | 2022-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000000014049350667 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Shandon Diagnostics Limited | 25 |
| Thermo Fisher | Shandon Diagnostics Limited | 11 |
| HistoCore Peloris | Leica Biosystems Melbourne PTY Ltd | 9 |
| Tissue-Tek Xpress® | Sakura Finetek U.S.A., Inc. | 3 |
| Tissue-Tek VIP® 6 | Sakura Finetek U.S.A., Inc. | 2 |
| PathTezt® | Biocytech Corporation SDN BHD | 2 |
| Tissue-Tek VIP® | Sakura Finetek U.S.A., Inc. | 2 |
| Basket | Leica Biosystems Nussloch Gmbh | 1 |
| Basket, assy., large | Leica Biosystems Nussloch Gmbh | 1 |
| Anybattery | Anybattery, Inc | 1 |
| Leica ASP300 S | Leica Biosystems Nussloch Gmbh | 1 |
| HistoPro® | Rushabh Instruments, LLC | 1 |
Showing 12 of 52. All products under Processor, Tissue, Automated
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 |
|---|---|---|---|---|
| 2024-04-10 | Class II | Device Design | Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks. | 141 devices |
| 2023-11-20 | Class II | Other | There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols. | 98 devices |
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.