Leica Biosystems
Frostbite
2manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Hubei (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Record
| Listed by | Leica Biosystems Richmond, Inc., United States |
|---|---|
| FDA product code | LEA |
| Device type | Preservative, Cytological |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3803200 | 6 | In distribution | |
| 000000000003803100 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epredia | Richard-Allan Scientific LLC | 28 |
| PathTezt® | Biocytech Corporation SDN BHD | 17 |
| ThinPrep | Hologic, Inc. | 12 |
| Streck Cell Preservative | Streck LLC | 4 |
| BD CytoRich™ Clear Preservative | Becton, Dickinson AND Company | 1 |
| MES: Freeze Medium | Lonza Walkersville, Inc. | 1 |
| Pre-prcs Prtm Frz Sol 131P0103, 50L drum | Lonza Walkersville, Inc. | 1 |
| Supmedic | Supmedics Inc. | 1 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 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 |
|---|---|---|---|---|---|
| 2012-02-20 | Not classified | Process design | Product was distributed with the incorrect lot number and expiration date. The lot number and expiration date should have been listed at 073013 and instead was noted as 073014 which is beyond the maximum expiration dating of 18 months for t | 11 cases | 2012-09-20 |
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.