Medical device manufacturer
Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics, Inc. holds 142 FDA 510(k) clearances across 77 product codes. Median elapsed review time is 57 days. openFDA lists 354 recall records naming the company. FDA publishes it under 21 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 142
- Product codes
- 77
- Median review
- 57 days
- Recall records
- 354
How does FDA spell Ortho-Clinical Diagnostics, Inc.?
FDA publishes this company under 21 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| ORTHO-CLINICAL DIAGNOSTICS | device/recall | normalised |
| ORTHO-CLINICAL DIAGNOSTICS | device/enforcement | normalised |
| ORTHO-CLINICAL DIAGNOSTICS, INC. | device/registrationlisting | normalised |
| Ortho Clinical Diagnostics | device/enforcement | normalised |
| Ortho Clinical Diagnostics | device/recall | normalised |
| Ortho Clinical Diagnostics | device/registrationlisting | normalised |
| Ortho Clinical Diagnostics | device/510k | normalised |
| Ortho Clinical Diagnostics Inc | device/recall | normalised |
Showing 8 of 21.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Ortho-Clinical Diagnostics, Inc. file in?
77 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 13 | 28 days | |
| MMI | Immunoassay Method, Troponin Subunit | 6 | 85 days | |
| JFY | Enzymatic Method, Creatinine | 5 | 23 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 28 days | |
| JIT | Calibrator, Secondary | 4 | 45 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 4 | 18 days | |
| CGZ | Electrode, Ion-Specific, Chloride | 3 | 90 days | |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 28 days | |
| DHX | System, Test, Carcinoembryonic Antigen | 3 | 71 days | |
| JIS | Calibrator, Primary | 3 | 19 days | |
| KHS | Enzymatic, Carbon-Dioxide | 3 | 143 days | |
| CDD | Radioassay, Vitamin B12 | 2 | 50 days | |
| CDN | Urease, Photometric, Urea Nitrogen | 2 | 29 days | |
| CEM | Electrode, Ion Specific, Potassium | 2 | 29 days | |
| CEW | Radioimmunoassay, Parathyroid Hormone | 2 | 105 days | |
| CGA | Glucose Oxidase, Glucose | 2 | 30 days | |
| CGN | Acid, Folic, Radioimmunoassay | 2 | 12 days | |
| CGR | Radioimmunoassay, Cortisol | 2 | 50 days | |
| CIX | Bromcresol Green Dye-Binding, Albumin | 2 | 19 days | |
| CJY | Azo Dye, Calcium | 2 | 21 days | |
| DHA | System, Test, Human Chorionic Gonadotropin | 2 | 115 days | |
| DLZ | Enzyme Immunoassay, Phenobarbital | 2 | 56 days | |
| JGS | Electrode, Ion Specific, Sodium | 2 | 41 days | |
| JHX | Fluorometric Method, Cpk Or Isoenzymes | 2 | 21 days | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 56 days |
Showing the 25 they file in most, of 77.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Ortho-Clinical Diagnostics, Inc. had a recall?
openFDA lists 354 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-2559-2025Class IIOpen, ClassifiedKHP
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Z-2560-2025Class IIOpen, ClassifiedKHP
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.
Z-2335-2025Class IIOpen, ClassifiedCJY
Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.
Z-2073-2025Class IIOpen, ClassifiedDJG
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
Z-2120-2025Class IIOpen, ClassifiedDIH
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 stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
Showing the 5 most recently initiated of 354.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Ortho-Clinical Diagnostics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252393 | VITROS Immunodiagnostic Products hs Troponin I Reagent Pack | MMI | 90 | |
| K241534 | VITROS Immunodiagnostic Products Syphilis Reagent Pack | LIP | 90 | |
| K233581 | VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack | DHA | 183 | |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | CEW | 498 | |
| K231517 | VITROS Immunodiagnostic Products CEA Reagent Pack | DHX | 90 | |
| K231525 | VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack | NIG | 75 | |
| K221355 | VITROS Immuodiagnostic Products CA 125 II Reagent Pack | LTK | 216 | |
| K213626 | VITROS AFP | LOJ | 210 | |
| K212648 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | JHX | 158 | |
| K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | NBC | 504 |
Source: openFDA device/510k · retrieved
Where is Ortho-Clinical Diagnostics, Inc. registered?
FDA lists 9 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Ortho-Clinical Diagnostics, Inc. files next
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.