Vitros
VITROS Immunodiagnostic Products Testosterone Calibrators
3manufacturers in China registered for this device type
6catalogue numbers in this listing
4510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | JIX |
| Device type | Calibrator, Multi-Analyte Mixture |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-23 |
| Record revised | 2025-02-19 (version 6) |
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, manufacturing date |
| Storage | Storage environment temperature -18 to -18 °C |
| Packaging | Case of 30, case of 60 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1882208 | In distribution | |
| 1662659 | In distribution | |
| 6802310 | In distribution | |
| 1290709 | In distribution | |
| 6844508 | In distribution | |
| 1306026 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 54 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 32 |
| Plasma Calibrator Set | Chromsystems Instruments & Chemicals Gmbh | 22 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 20 |
| Nova | Nova Biomedical Corporation | 15 |
| Plasma Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 15 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 15 |
| Architect | Abbott Laboratories | 11 |
| Alinity | Abbott Medical | 10 |
| Synchron | Beckman Coulter, Inc. | 9 |
| Architect | Abbott Medical | 9 |
| Urine Calibration Standard | Chromsystems Instruments & Chemicals Gmbh | 8 |
Showing 12 of 229. All products under Calibrator, Multi-Analyte Mixture
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161140 | 2016-05-20 |
| K071801 | 2007-07-20 |
| K060940 | 2006-04-24 |
| K023876 | 2002-12-10 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2019-12-16 | Class II | Under Investigation by firm | Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2 | 39709 units (12734 US and 26975 OUS) | 2020-11-12 |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2019-07-08 | Class II | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 2023-10-19 | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2019-07-08 | Class II | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 2023-10-19 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-02-18 | Class II | Process design | Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will start with the newest Generation (GEN) of VITROS Fe Slides (GEN 26), the potential shift in TIBC patient values of GEN 26 and above will be approx | 7546 US and 15280 OUS kits | 2022-10-18 |
| 2019-07-08 | Class II | Software design | Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System | 55 | 2023-10-19 |
| 2018-07-11 | Class III | Under Investigation by firm | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyceride concentration 600mg/dL, however the | 420105 | 2020-08-11 |
| 2014-07-15 | Class II | Process control | Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems. | 5906 total: 240 (US); 5666 (OUS) | 2018-05-21 |
| 2013-10-17 | Class II | Under Investigation by firm | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results. | 19,368 units total (10,328 for lot 212 and 9,040 for lot 292 | 2018-05-18 |
| 2013-04-03 | Class III | Process control | Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results. | Domestic: 3019 units, Foreign: 905 units | 2017-03-02 |
| 2012-02-02 | Not classified | Software design | Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Rele | 4306 | |
| 2011-10-13 | Not classified | Component design/selection | Ortho Clinical Diagnostics (OCD) was notified by customers of negatively biased quality control results obtained while using VITROS Chemistry Products NBIL DT Slides, GEN 72. OCD performed an internal investigation and confirmed that negati | 12,750 units (Lot 37: domestic – 1403, foreign – 3488; Lot 3 | 2016-02-12 |
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.