Recall Z-2444-2021 ยท JQP Calculator/Data Processing Module, For Clinical Use
Roche Diagnostics Operations, Inc.
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
| Date | Jun 24, 2021 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction notification letter dated 6/24/21 was sent to customers. Actions Required " Follow the Workaround section of this Urgent Medical Device Correction (UMDC), if applicable. " Consult with the physician or pathologist at your facility to determine any clinical implications specific to your patients. " Until the service patch is available, use the workaround described in this UMDC. " Complete all sections of the enclosed faxback form (TP-01337) and fax it to 1-847-457-1389 or email it to roche6071@stericycle.com. " File this UMDC for future reference. Identifyi |
| Quantity | 2058 licenses worldwide, 79 licenses in US |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.