Reported Sep 22, 2021 · Terminated
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
- Lot codes and dates
- UDI04015630936007; All systems running software version 3.01.03 - 3.02.08
- Amount recalled
- 2058 licenses worldwide, 79 licenses in US
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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