cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Reported: September 22, 2021 Initiated: June 24, 2021 #Z-2444-2021
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 2058 licenses worldwide, 79 licenses in US
- Distribution
- US Nationwide distribution
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 2058 licenses worldwide, 79 licenses in US.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 22, 2021. Severity: Moderate. Recall number: Z-2444-2021.
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