Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Roche. FDA records under 5 spellings of its name, each linked to the record. See the Roche group view.
As of Nov 13, 2026, FDA's public records list Roche Diagnostics with 459 510(k) clearances and 39 device recalls. The most recent is a 510(k) clearance dated Oct 20, 2026: Elecsys HBsAg II quant II RxDx.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Oct 20, 2026 | Elecsys HBsAg II quant II RxDxDEN260027 · SJM | 510(k) clearances |
| Oct 2, 2026 | Elecsys EBV IgMK260233 · LJN | 510(k) clearances |
| Oct 2, 2026 | Elecsys EBV VCA IgGK260232 · LSE | 510(k) clearances |
| Oct 2, 2026 | Elecsys EBV EBNA IgGK260221 · LSE | 510(k) clearances |
| Aug 19, 2026 | Elecsys Phospho-Tau (217P) PlasmaK261686 · SET | 510(k) clearances |
| Jun 12, 2026 | cobas pulse blood glucose monitoring systemK252323 · PZI | 510(k) clearances |
| Apr 24, 2026 | Elecsys CalcitoninK252431 · JKR | 510(k) clearances |
| Apr 13, 2026 | Elecsys Anti-SARS-CoV-2 SK252280 · QVP | 510(k) clearances |
| Jun 3, 2019 | The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody cClass II · Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures h | Device recalls |
| Apr 4, 2019 | cobas p 501 post-analytical units, Part Number 05158494001. For diagnostic sample storage and retrieval.Class III · There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from th | Device recalls |
| Apr 4, 2019 | cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.Class III · There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from th | Device recalls |
| Mar 18, 2019 | Albumin BCP Product Usage: ALBP is an in vitro test used for the quantitative determination of albumin in human serum and plasma on RocClass II · The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level ca | Device recalls |
| Mar 15, 2019 | cobas e 801 immunoassay analyzerClass II · The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeove | Device recalls |
| Feb 4, 2019 | Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical UseClass II · Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from | Device recalls |
| Dec 17, 2018 | Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro Class II · New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and t | Device recalls |
| Dec 17, 2018 | Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05Class II · New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and t | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
