Recall Z-1368-2019— Roche Diagnostics Corporation
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2019-02-04, terminated 2020-09-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use. Reason: 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..
- Recalling firm
- Roche Diagnostics Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-02-04
- Terminated
- 2020-09-16
- Firm location
- Indianapolis, IN, United States
Product description
Cobas¿ infinity central lab IT solution Material Number: 07154003001 Calculator/Data Processing Module, For Clinical Use
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.