Vitros
VITROS Chemistry Products PHOS Slides
2manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jilin (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | CEO |
| Device type | Phosphomolybdate (Colorimetric), Inorganic Phosphorus |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1580 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-04-18 |
| Record revised | 2023-04-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C; Special storage condition: Can also store at or below -18 |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1513209 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Pointe Scientific, Inc. Phosphorus | Horiba Instruments Incorporated | 6 |
| Carolina Liquid Chemistries Corp.® Phosphorus Reagent KIT AU-218 | Carolina Liquid Chemistries | 5 |
| JAS Diagnostics | Drew Scientific, Ltd. | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 4 |
| Phosphate (Inorganic) ver.2 | Roche Diagnostics Gmbh | 3 |
| Inorganic Phosphorous (Phos) | Randox Laboratories Limited | 3 |
| Pointe Phosphorus Reagent | Horiba Instruments Incorporated | 2 |
| Architect | Abbott Medical | 2 |
| Architect | Abbott Laboratories | 2 |
| Architect | Abbott Ireland | 2 |
Showing 12 of 40. All products under Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | UDI-DI | 2025-04-24 | Class II | Storage | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result | 10 units |
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 |
|---|---|---|---|---|---|
| 2013-06-12 | Class II | Equipment maintenance | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. | 81,382 units (28,256 units domestically & 53,126 units inter | 2017-04-11 |
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.