VERIGENE Processor SP recall
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Why was VERIGENE Processor SP recalled?
No results/incorrect results due to failure of the hybridization heater.
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?
Catalogue Number: 10-0000-07 Serial No. 14230205 UDI Code: 00857573006010
- Product
- VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
- Recalling firm
- Luminex Corporation
- Quantity
- 1 system
- Distribution
- US distribution in MO. No OUS
- Recall date
- October 14, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)