The Recall Desk
HighFDA (Devices)·Z-0952-2023·Announced 2023-01-18

Medical device software bug may cause patient sample order mismatches in rare cases

A software bug in Roche Diagnostics' cobas infinity central lab may cause orders to be mismatched to wrong patient samples under rare circumstances. The issue affects 224 US units and 2,797 devices worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with potential for patient sample misidentification. No illnesses or injuries have been reported, but the hazard represents a direct risk of patient harm if orders are mismatched to wrong samples. The condition requires specific configuration parameters that are uncommon in U.S. installations.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling the cobas infinity central lab (Material Number 07154003001), a software-controlled diagnostic analyzer used in clinical laboratory settings. The recall affects approximately 224 units distributed in the United States and 2,797 units worldwide.

A software bug in the Host Connectivity Agent (HCA) order rejection capability can cause the system to malfunction under specific conditions. When a sample barcode date does not match the order date from the Laboratory Information System (LIS), the system may create an order with an Internal ID instead of the correct External ID. This error could result in an order being matched to another patient's sample ID rather than the intended patient's sample ID.

The issue occurs only with cobas infinity central lab software versions 2.5.x, 3.01.x, 3.02.x, and 3.03.x when configured with specific settings: Order ID configuration that includes the date, a host configured by order rather than by tube, message configuration to receive order registration date, and HCA configuration with the specified rejection settings enabled. Roche notes that these configurations are uncommon in U.S. laboratory settings.

The recalled product

Product
cobas infinity central lab, Material Number 07154003001
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — Laboratory Equipment
Hazard
  • patient-misidentification
  • software-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 3.01.x
  • 3.02.x

Distribution

Distributed nationwide across the United States.

Related recalls

Same category