Roche Diagnostics Operations, Inc.: Medical Device Recall in 2023 - (Recall #: Z-0952-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

cobas infinity central lab, Material Number 07154003001

Product Classification:

Class II

Date Initiated: December 12, 2022

Date Posted: January 18, 2023

Recall Number: Z-0952-2023

Event ID: 91299

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 224 US; 2,797 worldwide

Code Information:

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

Distribution Pattern:

Domestic distribution nationwide. Foreign distribution pending.

Voluntary or Mandated:

Voluntary: Firm initiated