CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report
Cobas¿ infinity central lab IT solution Material Number recalled
Roche Diagnostics is recalling Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data, distributed in 11 states. The recall was initiated on 4 Feb 2019 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-1368-2019
- FDA event ID
- 82139
- Recalling firm
- Roche Diagnostics, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Feb 2019
- FDA classified
- 17 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 4 Feb 2019 | Recall initiated by company | |
| 17 May 2019 | Classified by FDA | +102 days |
| 29 May 2019 | 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
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
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 IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
Where it was distributed
US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
AlabamaArizonaCaliforniaGeorgiaIowaMissouriNew JerseyNew YorkSouth CarolinaTennesseeTexas
Questions about this recall
Is Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data recalled?
Yes. Roche Diagnostics recalled Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data on 4 Feb 2019. The recall is Class II and its status is Terminated. Recall number Z-1368-2019.
Why was it recalled?
Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality control (QC) alarm when one should be present. If the QC is out of range on the stand-by bottle and it is not removed from the system, there is a potential that when the status of the Standby bottle changes from the Standby bottle to the Current bottle status, QC alarms will not be displayed next to the sample result.
Which lots are affected?
Software versions 2.0 thorough 2.5 Serial Numbers: 81191 81371 81385 81465 81469 81470 81481 81485 81527 81528 81618 81628 81652 81655 81662
Where was it sold?
US Distribution to states of: AL, AZ, CA, GA, IA, MO, NJ, NY, SC, TN and TX.
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 21 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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