CLASS II Device recall · Reported 25 Nov 2020 · FDA Enforcement Report
cobas infinity central lab/cobas infinity core license recalled
Roche Diagnostics Operations is recalling cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions, distributed nationwide in the US. The recall was initiated on 9 Oct 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-0461-2021
- FDA event ID
- 86609
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2020
- FDA classified
- 17 Nov 2020
- Reported
- 25 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 9 Oct 2020 | Recall initiated by company | |
| 17 Nov 2020 | Classified by FDA | +39 days |
| 25 Nov 2020 | 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
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule
Which lots are affected?
Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 81967 81946 82121 82027 82194 82120 81528 82231 81958 82246 81983 82118 82165 81886 82082 82256 82257 81781 82331 82304 82087 82276 81465 81959 82235 82180 82181 82236 81945 82275 81662 82065 82253 81817 82000
Where was it sold?
Nationwide
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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| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |