FDA Device recall Z-0952-2023
cobas infinity central lab, Material Number 07154003001
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of cobas infinity central lab, Material Number 07154003001 by Roche Diagnostics Operations, citing 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 recei….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0952-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-12 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
cobas infinity central lab, Material Number 07154003001
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 multiple cobas infinity central lab software (versions 2.5.x , 3.01.x, 3.02.x, and 3.03.x) and occurs when the afflicted software has been configured with specific pre-conditions.
Identifiers
| code_info | cobas infinity central lab / cobas infinity core license using software versions (2.5.x , 3.01.x, 3.02.x, and 3.03.x) t…cobas infinity central lab / cobas infinity core license using software versions (2.5.x , 3.01.x, 3.02.x, and 3.03.x) that have been configured with all of the following pre-conditions will be impacted: 1. Having Order ID configuration to include the date (Not Common in U.S. Configurations) 2. Having a host configured by Order rather than Tube (Not Common in U.S..Configurations) 3. Having message configured to receive registration date of the order using ExtRegisterDate and ExtRegisterHour. 4. Having HCA configuration enabled for " Reject orders if not possible to assign External ID" and the radio button option set to "To at least one test" UDI-DI 04015630936007 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0952-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.