Verigene Enteric Pathogens Nucleic Acid Test recall
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Why was Verigene Enteric Pathogens Nucleic Acid Test recalled?
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
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?
UDI/DI 00840487101568, Lot Numbers: 071322023D, 071822023B, 071822023C, 071922023E, 072022023D, 072622023D, 082422023G, 083022023E, 083122023E, 090622023A, 090822023D, 091322023D, 091422023D, 091422023E, 092022023E, 092122023D, 092722023D, 092822023D, 100422023D, 100722023E, 101422023E, 101822023D, 101822023E, 101922023D, 102022023D, 121322023D, 122722023C, 122722023D, 010323023D, 011323023G, 021323023A, 021323023B, 021523023D, 022123023E, 022323023D, 030123023F, 030223023D, 030223023E, 030623023A, 030823023D, 031623023D
- Product
- Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
- Recalling firm
- Luminex Corporation
- Quantity
- 3987 units
- Distribution
- Worldwide and US Nationwide Distribution
- Recall date
- July 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)