Verigene Processor SP recall
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Why was Verigene Processor SP recalled?
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
- Recalling firm
- Luminex Corporation
- Quantity
- 24 units
- Distribution
- US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None
- Recall date
- May 25, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)