CLASS II Device recall · Reported 6 Jan 2021 · FDA Enforcement Report
cobas pro integrated solutions -cobas c 503, Analyzer recalled
Roche Diagnostics Operations is recalling cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), distributed in Florida, Georgia, Illinois, West Virginia. The recall was initiated on 23 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0752-2021
- FDA event ID
- 86897
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Nov 2020
- FDA classified
- 29 Dec 2020
- Reported
- 6 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Nov 2020 | Recall initiated by company | |
| 29 Dec 2020 | Classified by FDA | +36 days |
| 6 Jan 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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).
Product as listed by the FDA
cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
Where it was distributed
Domestic: IL, FL, GA, WV
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Catalog Number 08445605190 08445567190 08253153190 08058580190
Where was it sold?
Domestic: IL, FL, GA, WV
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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