cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Mat
Summary
The FDA issued a Class II for cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for by Roche Molecular Systems, Inc.. Reason: The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza.
Details
Source
Device Recall
External ID
Z-1106-2023
Action Date
2023-02-15
Status
Ongoing
Category
device
Product Description
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
Lot/Code Info: UDI-DI 00875197006773 All in-date lots
Quantity Affected: 727 kits OUS only
Reason for Recall
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional testing, psychological distress, and delays to targeted therapy for influenza as well as true diagnosis.
Distribution
Domestic distribution nationwide. Foreign distribution worldwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-12-21
Company
Branchburg, NJ
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 163 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Roche Molecular Systems, Inc. has 27 FDA actions in our database, including 7 recalls and 20 clearances.
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 Molecular Systems, 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 Molecular Systems, Inc. have FDA actions?
Roche Molecular Systems, Inc. has 27 FDA actions in our database, including 7 recalls and 20 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1106-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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