Medical device manufacturer
Roche Diagnostics Corporation
Roche Diagnostics Corporation holds 455 FDA 510(k) clearances across 146 product codes. Median elapsed review time is 74 days. openFDA lists 240 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 455
- Product codes
- 146
- Median review
- 74 days
- Recall records
- 240
How does FDA spell Roche Diagnostics Corporation?
FDA publishes this company under 8 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 |
|---|---|---|
| ROCHE DIAGNOSTICS GMBH | device/registrationlisting | normalised |
| Roche Diagnostics | device/510k | normalised |
| Roche Diagnostics Corp. | device/recall | normalised |
| Roche Diagnostics Corp. | device/510k | normalised |
| Roche Diagnostics Corporation | device/enforcement | normalised |
| Roche Diagnostics Corporation | device/recall | normalised |
| Roche Diagnostics Corporation | device/510k | normalised |
| Roche Diagnostics GmbH | device/510k | normalised |
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 Roche Diagnostics Corporation file in?
146 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 60 | 48 days | |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 22 | 37 days | |
| NBW | System, Test, Blood Glucose, Over The Counter | 19 | 74 days | |
| JIT | Calibrator, Secondary | 18 | 28 days | |
| GJS | Test, Time, Prothrombin | 14 | 108 days | |
| JIX | Calibrator, Multi-Analyte Mixture | 14 | 38 days | |
| LFR | Glucose Dehydrogenase, Glucose | 12 | 29 days | |
| DKZ | Enzyme Immunoassay, Amphetamine | 10 | 68 days | |
| CGN | Acid, Folic, Radioimmunoassay | 7 | 140 days | |
| JZO | System, Test, Thyroid Autoantibody | 7 | 119 days | |
| NBC | Test, Natriuretic Peptide | 7 | 166 days | |
| CFR | Hexokinase, Glucose | 6 | 40 days | |
| MMI | Immunoassay Method, Troponin Subunit | 6 | 69 days | |
| DKB | Calibrators, Drug Mixture | 5 | 62 days | |
| JIS | Calibrator, Primary | 5 | 21 days | |
| LCM | Enzyme Immunoassay, Phencyclidine | 5 | 62 days | |
| LCP | Assay, Glycosylated Hemoglobin | 5 | 190 days | |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 4 | 114 days | |
| CEM | Electrode, Ion Specific, Potassium | 4 | 28 days | |
| CEW | Radioimmunoassay, Parathyroid Hormone | 4 | 49 days | |
| CIG | Diazo Colorimetry, Bilirubin | 4 | 49 days | |
| DCN | System, Test, C-Reactive Protein | 4 | 106 days | |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 4 | 49 days | |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 | 66 days | |
| JGS | Electrode, Ion Specific, Sodium | 4 | 97 days |
Showing the 25 they file in most, of 146.
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 Roche Diagnostics Corporation had a recall?
openFDA lists 240 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-1979-2019Class IITerminatedCZP
Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reagent.
Z-1927-2019Class IIITerminatedJQP
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Z-1928-2019Class IIITerminatedJQP
There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument.
Z-1194-2019Class IITerminatedCJW
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Z-1249-2019Class IITerminatedJJE
The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment.
Showing the 5 most recently initiated of 240.
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 Roche Diagnostics Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252323 | cobas pulse blood glucose monitoring system | PZI | 322 | |
| K252431 | Elecsys Calcitonin | JKR | 266 | |
| K252280 | Elecsys Anti-SARS-CoV-2 S | QVP | 265 | |
| K260049 | Elecsys Anti-HBc IgM | SEI | 90 | |
| K260048 | Elecsys Anti-HAV IgM | LOL | 90 | |
| K260046 | Elecsys Anti-HBc II | SEI | 90 | |
| K260026 | Tina-quant Cardiac high sensitivity CRP III | NQD | 87 | |
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions | CEM | 111 | |
| K253490 | Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions | CFR | 111 | |
| K253839 | Elecsys Anti-SARS-CoV-2 | QVP | 16 |
Source: openFDA device/510k · retrieved
Where is Roche Diagnostics Corporation registered?
FDA lists 2 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 Roche Diagnostics Corporation 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.