FDA-Device2023-01-18Class II

cobas infinity central lab, Material Number 07154003001

Roche Diagnostics Operations, Inc.

Hazard

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.

Sold states

Domestic distribution nationwide. Foreign distribution pending.

Affected count

224 US; 2,797 worldwide

Manufactured in

9115 Hague Rd, Indianapolis, IN, United States

Products

cobas infinity central lab, Material Number 07154003001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0952-2023

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