cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid T
Summary
The FDA issued a Class II for cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase C by Roche Molecular Systems, Inc.. Reason: Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses..
Details
Source
Device Recall
External ID
Z-0097-2023
Action Date
2022-10-26
Status
Terminated
Category
device
Product Description
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
Lot/Code Info: Device Identifier: 07613336170076 All serial IDs are affected.
Quantity Affected: 179 OUS
Reason for Recall
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Distribution
International distribution in the countries of Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Italy, Lithuania, Poland, Portugal, Spain, Sweden, Switzerland, UK, Chile, Colombia, Hong Kong, Jamaica, Japan, Nicaragua, Oman, Pakistan, UAE.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-08
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 184 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-0097-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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