cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001

Recall Insight

This FDA Devices action (record #Z-2444-2021) was formally reported on September 22, 2021, with the manufacturer initiating the action on June 24, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Roche Diagnostics Operations, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records indicate 2058 licenses worldwide, 79 licenses in US units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: Under specific circumstances created by the user, the cobas e flow test results could be replaced by an automatic result sent to the lab LIS. This automatic result could be released and interpreted by your Laboratory In… Distribution data in the federal record shows the product reached: US Nationwide distribution. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 5 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.