Recall Z-1158-2020 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
| Date | Jan 7, 2020 |
| Status | Terminated |
| Reason | Alarm flags that have a "<" symbol in front of them are not displayed on the cobas infinity Validation screen. This issue affects only customers that are doing manual validation on the cobas infinity Validation screen. |
| Root cause | Under Investigation by firm |
| Action | On 1/7/2020, the firm distributed Urgent Medical Device Correction letters to affected consignees. Customers were asked to do the following: " Be aware of the incorrect display of the alarm flags on the cobas infinity Validation screen if an alarm has a < symbol in front of it and if doing manual validations. " It is not recommended to use the alarm mapping function on the cobas infinity until your system is patched. If your laboratory does use it, please call the Roche Support Network Customer Support Center at 1-800-526-2272 for further information. " Complete the customer response form a |
| Quantity | 26 accounts |
| Distribution | Distributed to customers in AK, AL, CA, GA, HI, IA, IL, KY, MA, MI, MN, MO, MS, MT, NJ, NY, OR, SC, and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.