Epredia
Formal-Fixx is a variation of neutral buffered formalin with a differing buffering system. This fixative is designed especially for use with the Cytoblock processing gel. The phosphate-free…
Formal-Fixx is a variation of neutral buffered formalin with a differing buffering system. This fixative is designed especially for use with the Cytoblock processing gel. The phosphate-free buffering system prevents the formation of free formic acid, and its associated artifacts, formalin pigment. The osmolality of these fixatives allows them to be used not only for light microscopy but for electron microscopic studies as well. Zinc Formal-Fixx Concentrate is the same formulation as Formal-Fixx Concentrate but includes the mineral zinc to enhance the nuclear detail of the specimen.
Who Else Makes It
Concentrated in Jiangsu (2), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Citotest Labware Manufacturing Co., Ltd. | Haimen | Jiangsu | Repacker / relabeller | 46 |
| Citotest Scientific Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 46 |
| Wuhan Landing Intelligence Medical Co., Ltd. | Wuhan | Hubei | Manufacturer | 17 |
Record
| Listed by | Richard-Allan Scientific LLC, United States |
|---|---|
| FDA product code | LDY |
| Device type | Fixative, Formalin-Containing |
| Device class | Class 1 |
| Regulation | 21 CFR 864.4010 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-07-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Zinc Buffered Formalin Prefilled Container | In distribution | |
| Formal-Fixx™ | In distribution | |
| Formal-Fixx™ | In distribution | |
| Zinc Buffered Formalin Prefilled Container | In distribution | |
| Formal-Fixx™ | In distribution | |
| Formal-Fixx™ Concentrate | In distribution | |
| Carson’s Modified Buffered Formalin | In distribution | |
| Zinc Formal-Fixx™ | In distribution | |
| Zinc Buffered Formalin Prefilled Container | In distribution | |
| 10% Alcoholic Formalin Unbuffered | In distribution | |
| Formal-Fixx™ | In distribution | |
| Zinc Buffered Formalin Prefilled Container | In distribution | |
| Formal-Fixx™ Concentrate | In distribution | |
| Formal-Fixx™ | In distribution | |
| Zinc Buffered Formalin Prefilled Container | In distribution | |
| Zinc Formal-Fixx™ Concentrate | In distribution | |
| Formal-Fixx™ | In distribution | |
| Zinc Buffered Formalin | In distribution | |
| Zinc Buffered Formalin Prefilled Container | In distribution | |
| Zinc Formalin Unbuffered | In distribution | |
| Zinc Buffered Formalin Prefilled Container | In distribution | |
| Zinc Buffered Formalin | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Thermo Scientific Protocol™ Parasitology System | Fisher Diagnostics | 11 |
| Endiscope and accessories | Elliquence LLC | 4 |
Recalls
7 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-09-17 | Class I | Mixed-up of materials/components | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | 235 cases | 2016-10-27 |
| 2014-09-17 | Class I | Mixed-up of materials/components | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | 264 cases | 2016-10-27 |
| 2014-09-17 | Class I | Mixed-up of materials/components | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | 383 cases | 2016-10-27 |
| 2014-09-17 | Class I | Mixed-up of materials/components | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | 80 cases | 2016-10-27 |
| 2014-09-17 | Class I | Mixed-up of materials/components | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | 285 cases | 2016-10-27 |
| 2014-09-17 | Class I | Mixed-up of materials/components | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | 199 cases | 2016-10-27 |
| 2014-09-17 | Class I | Mixed-up of materials/components | The affected lots could have NBF concentrations that are lower or higher than the desired specifications. | 175 cases | 2016-10-27 |
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.