Food, drugs, devices › Roche Diagnostics Operations, Inc.
Device recall: cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
FDA enforcement event 88398 is a device recall by Roche Diagnostics Operations, Inc. of Indianapolis, IN, initiated 24 Jun 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 21 Jul 2023. Initiation: voluntary: firm initiated. Roche Diagnostics Operations, Inc. has 69 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Roche Diagnostics Operations, Inc., Indianapolis, IN.
Reason for recall
"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 Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument."
Distribution
"US Nationwide distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2444-2021 | cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 | 2058 licenses worldwide, 79 licenses in US | Class II | Terminated | 22 Sep 2021 |
Context
Other enforcement events for Roche Diagnostics Operations, Inc.
All 69 events for Roche Diagnostics Operations, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 Information System (LIS) as a false positive or negative result. It should be noted that the "correct" result would still be available on the instrument."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 21 Jul 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.