Vitros
VITROS Chemistry Products CHE Slides
1manufacturer
2catalogue numbers in this listing
5recalls on this code
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | DIH |
| Device type | Colorimetry, Cholinesterase |
| Device class | Class 1 |
| Regulation | 21 CFR 862.3240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2020-04-18 |
| Record revised | 2023-06-21 (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 -18 to -18 °C; Special storage condition: Store at or below -18 |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8004707 | In distribution | |
| 1914605 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 13 |
| Advia® Chemistry CHE Cholinesterase Reagents | Siemens Healthcare Diagnostics Inc | 2 |
| Cholinesterase Gen.2 | Roche Diagnostics Gmbh | 2 |
| Butyryl Cholinesterase (CHE) | Randox Laboratories Limited | 2 |
| Dimension Vista® Flex® reagent cartridge Pche | Siemens Healthcare Diagnostics Inc | 1 |
| AChE Assay Kit | EQM Research, Inc. | 1 |
| Arena Star | Arum Dentistry Co., Ltd. | 1 |
| PChE Assay Kit | EQM Research, Inc. | 1 |
| Test-mate ChE Cholinesterase Test System | EQM Research, Inc. | 1 |
| Atellica CH CHE | Siemens Healthcare Diagnostics Inc | 1 |
| Cholinesterase | Roche Diagnostics Gmbh | 1 |
| Atellica CH Cholinesterase_2 | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 14. All products under Colorimetry, Cholinesterase
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 |
|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2025-06-10 | Class II | Under Investigation by firm | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stabilit | 27, 330 US/ 19,679,730 OUS |
Recalls
4 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 | Closed |
|---|---|---|---|---|---|
| 2025-06-10 | Class II | Under Investigation by firm | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stabilit | 36005 Units (US)/22,302 units OUS | |
| 2025-06-10 | Class II | Under Investigation by firm | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stabilit | 414,000 (OUS) | |
| 2025-06-10 | Class II | Under Investigation by firm | Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stabilit | 37429 units (US)/11,703 units (OUS) | |
| 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. | 11,135 units (153 units domestically & 10,982 internationall | 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.