Vitros
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators
1manufacturer
39catalogue numbers in this listing
4510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Ortho-Clinical Diagnostics, Inc., United States |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K221197 |
| 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 | Special storage condition: Do not freeze; Storage environment temperature 2 to 8 °C |
| Packaging | Case of 30, case of 60, case of 25, case of 150, case of 36 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6800189 | In distribution | |
| 6801771 | In distribution | |
| 6802323 | In distribution | |
| 8231474 | In distribution | |
| 6801701 | In distribution | |
| 6801704 | In distribution | |
| 6801873 | In distribution | |
| 6844424 | In distribution | |
| 6802157 | In distribution | |
| 1204668 | In distribution | |
| 6192256 | In distribution | |
| 6801745 | In distribution | |
| 6802221 | In distribution | |
| 6801772 | In distribution | |
| 6177752 | In distribution | |
| 6801703 | In distribution | |
| 6801707 | In distribution | |
| 6801700 | In distribution | |
| 6844055 | In distribution | |
| 6801708 | In distribution | |
| 6842906 | In distribution | |
| 6802302 | In distribution | |
| 6800035 | In distribution | |
| 6802342 | In distribution | |
| 6801702 | In distribution | |
| 6900053 | In distribution | |
| 6801744 | In distribution | |
| 1113596 | In distribution | |
| 6844426 | In distribution | |
| 6801768 | In distribution | |
| 8568040 | In distribution | |
| 1487289 | In distribution | |
| 6801706 | In distribution | |
| 6177334 | In distribution | |
| 6801705 | In distribution | |
| 6199327 | In distribution | |
| 1320498 | In distribution | |
| 6802893 | In distribution | |
| 8067324 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exact Diagnostics | Exact Diagnostics | 30 |
| Architect | Abbott Medical | 26 |
| Architect | Abbott Ireland | 24 |
| Alinity | Abbott Medical | 18 |
| Alinity | Abbott Ireland | 16 |
| Architect | Abbott Laboratories | 15 |
| Architect | Abbott Ireland Diagnostics | 11 |
| Alinity | Abbott Ireland Diagnostics | 11 |
| JAS Diagnostics | Drew Scientific, Ltd. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| AU | Beckman Coulter, Inc. | 6 |
| Fluid Pack | Diamond Diagnostics Inc. | 5 |
Showing 12 of 391. All products under Calibrator, Secondary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171168 | 2017-05-16 |
| K042838 | 2004-12-09 |
| K042521 | 2004-11-18 |
| K031924 | 2003-08-07 |
Recalls Naming This Product
9 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 | 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) | |
| 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 | 36005 Units (US)/22,302 units OUS | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2024-02-27 | Class II | Under Investigation by firm | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patien | 10,911 units | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2024-02-27 | Class II | Under Investigation by firm | The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patien | 11,224 units | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2023-06-05 | Class II | Process control | Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results. | 4,013 units | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2023-05-08 | Class II | Under Investigation by firm | Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM. Within the reference interval, the highest bias observed in selected sample testing inves | 2400 units | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2022-10-13 | Class II | Under Investigation by firm | Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots of slide generation 22 (GEN 22). The erroneous mathematics | 17,396 Units | |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 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 |
| Ortho-Clinical Diagnostics, Inc. | UDI-DI | 2020-10-16 | Class III | Under Investigation by firm | Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verifier II Lot Q7692 when stored unopened at refrigerated temperatures | 10788 total: US 4680; OUS 6108 |
Recalls
2 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 |
|---|---|---|---|---|---|
| 2023-11-21 | Class II | Storage | Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is expected to degrade the quality of the calibrator and render it unsuitable for use. Use of the | 10 sales units US; 1 sales unit OUS | |
| 2017-01-05 | Class III | Under Investigation by firm | The company received a customer complaint for the inability to calibrate VITROS Chemistry Products dLDL Reagent when using VITROS FS Calibrator 1, Lot 91461 and ADD (DRV 5908). Assay Data Disk (ADD) DRV versions 5904, 5905, 5906, 5907, 590 | US: 160 kits, Foreign: 642 kits | 2018-06-22 |
| 2016-04-19 | Class III | Employee error | There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay. | 520 Units | 2018-06-08 |
| 2015-09-28 | Class III | Under Investigation by firm | The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954. | Domestic: 2443 kits; Foreign: 1548 kits | 2018-05-22 |
| 2014-05-12 | Class II | Process change control | Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator val | Domestic – 612 units, Foreign – 461 units | 2017-03-23 |
| 2014-01-15 | Class III | Component design/selection | Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate nega | 1554 units domestically | 2017-04-03 |
| 2011-10-27 | Not classified | Nonconforming Material/Component | Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS Chemistry Products Calibrator Kit 24 and VITROS | 4436 units worldwide (domestic – 2201; foreign – 2235) | 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.