cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Summary
The FDA issued a Class II for cobas infinity central lab running software version 3.01.03 through 3.02.08, Cat by Roche Diagnostics Operations, Inc.. 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 aut.
Details
Source
Device Recall
External ID
Z-2444-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Lot/Code Info: UDI: 04015630936007; All systems running software version 3.01.03 - 3.02.08
Quantity Affected: 2058 licenses worldwide, 79 licenses in US
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-24
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Roche Diagnostics Operations, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Roche Diagnostics Operations, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Roche Diagnostics Operations, Inc. have FDA actions?
Roche Diagnostics Operations, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2444-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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