cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Summary
The FDA issued a Class II for cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog by Roche Molecular Systems, Inc.. Reason: Customers have reported an increased number of false positive SARS-CoV-2 results..
Details
Source
Device Recall
External ID
Z-2498-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Lot/Code Info: Lot 10119Z
Quantity Affected: 211 kits (US); 3073 kits (OUS)
Reason for Recall
Customers have reported an increased number of false positive SARS-CoV-2 results.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-04
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 173 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-2498-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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