Recall Z-0952-2023 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
cobas infinity central lab, Material Number 07154003001
| Date | Jan 12, 2023 (initiated Dec 12, 2022) |
| Status | Open, Classified |
| Reason | A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from the Laboratory Information System (LIS) is created with an Internal ID rather than the External ID sent from the LIS. The erroneous event occurs under rare circumstances where the date in the sample's barcode does not match the order date sent from the LIS, and can lead to the order being mismatched to an another patient's sample ID rather than the subject patient's sample ID. The software bug impacts multipl |
| Root cause | Software design |
| Action | On December 12, 2022, the firm notified affected customers through Urgent Medical Device Correction letters. Customers were informed of the product issue. A Roche Diagnostics representative will contact you in the near future to assess your cobas infinity configuration and to determine if it meets all pre-conditions. If so, your Roche representative will work with you to implement a workaround immediately in addition to working with you to apply a more permanent solution via a software patch once available. Customers should consult with a physician or pathologist at your facility to determin |
| Quantity | 224 US; 2,797 worldwide |
| Distribution | Domestic distribution nationwide. Foreign distribution pending. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.