Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Summary
The FDA issued a Class II for Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigen by Luminex Corporation. Reason: Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results..
Details
Source
Device Recall
External ID
Z-1092-2022
Action Date
2022-05-25
Status
Ongoing
Category
device
Product Description
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Lot/Code Info: Serial Numbers for 10-0000-07: 17340003 19044007 20133004 18128002 18214004 12061048 18191010 13193254 13051068 21029902 16277059 19233005 11250096 14069051 18255003 *18039010 *20212006 *19317004 *19206009 *18057008 Serial Numbers added 6.23.22 for 10-0000-07R: 18191010 13051068 14069051 *12198198 *12278344 *14322267 *12271338 Serial Numbers added 7.14.22 for 10-0000-07R: 18226007 and 16242043 Serial Numbers added 7.14.22 for 10-0000-07: 17062030, 18235008 and 19192006
Quantity Affected: 24 units
Reason for Recall
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
Distribution
US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-05
Company
Austin, TX
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Luminex Corporation has 26 FDA actions in our database, including 21 recalls and 5 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 (Luminex Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Luminex Corporation have FDA actions?
Luminex Corporation has 26 FDA actions in our database, including 21 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1092-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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