Recall Z-2444-2021— Roche Diagnostics Operations, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2021-06-24, terminated 2023-07-21. FDA's recall record names no specific 510(k) clearance for this event. Product: cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001. Reason: 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..
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-06-24
- Terminated
- 2023-07-21
- Firm location
- Indianapolis, IN, United States
Product description
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.