CLASS II Device recall · Reported 22 Sep 2021 · FDA Enforcement Report
cobas infinity central lab running recalled
Roche Diagnostics Operations is recalling cobas infinity central lab running, distributed nationwide in the US. The recall was initiated on 24 Jun 2021 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-2444-2021
- FDA event ID
- 88398
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jun 2021
- FDA classified
- 10 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 24 Jun 2021 | Recall initiated by company | |
| 10 Sep 2021 | Classified by FDA | +78 days |
| 22 Sep 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
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 running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Where it was distributed
US Nationwide distribution
Questions about this recall
Why was it recalled?
Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument.
Which lots are affected?
UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08
Where was it sold?
US Nationwide distribution
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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