Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0952-2023 — cobas infinity central lab, Material Number 07154003001

U.S. FDA — Device Enforcement · United States · 2022-12-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0952-2023
Date of alert
2022-12-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Diagnostics Operations, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
04015630936007
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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