Lower riskMedical device recall · FDA · Published November 23, 2020
Roche cobas c 5: inaccurate therapeutic drug monitoring results risk
Roche recalls cobas c 503 analyzers for inaccurate therapeutic drug monitoring results due to residual reagent transfer during testing. Affected units have specific catalog numbers.
During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the affected TDMs (Therapeutic Drug Monitoring).
“Roche cobas c 5: inaccurate therapeutic drug monitoring results risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63817-roche-cobas-c-5-inaccurate-therapeutic-drug-monitoring-results-risk. Based on FDA recall #Z-0752-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0752-2021%22&limit=1).
Roche Diagnostics Operations, Inc. recalled cobas pro integrated solutions -cobas c 503 analyzers on Nov. 23, 2020, according to the FDA. The hazard involves sporadic transfer of residual reagent leading to inaccurately low results for Therapeutic Drug Monitoring tests.
How to tell if you have it
Brand: Roche
Product: cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete)
During subsequent pipetting for the first or second measurement, residual reagent can sporadically transfer from the conus into the reaction cuvette. This leads to inaccurately low results for the affected Therapeutic Drug Monitoring (TDMs).
Context
GovInfoNow's records show Roche Diagnostics Operations, Inc. has 32 other recalls on record since July 2, 2019. Other recent recalls of similar products include Roche cobas pro integrated solutions recall (Jan. 20, 2026), Roche Elecsys Anti-TSHR Assay Recall (Nov. 21, 2025), and Roche cobas HCYS Assay Recall (Oct. 17, 2024). Other recent recalls of similar products include Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (July 13, 2026), and DxC 500i Clinical Analyzer Modules May Show Incorrect Test Results Due to Software Issue (Sept. 2, 2026).
How to tell if you have this one
Check if your analyzer has catalog numbers 08445605190, 08445567190, 08253153190, or 08058580190. These are specific models of the cobas c 503 analyzer used in clinical labs.
Brand
Roche
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Catalog Numbers
Identify if your analyzer has the catalog numbers 08445605190, 08445567190, 08253153190, or 08058580190.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “Domestic: IL, FL, GA, WV” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida, Georgia, Illinois, West Virginia.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0752-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0752-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.