Verigene CDF Nucleic Acid Test recall
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Why was Verigene CDF Nucleic Acid Test recalled?
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
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 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870; Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946; Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850; Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946.
- Product
- Verigene CDF Nucleic Acid Test, Part No. 30-002-22
- Recalling firm
- Luminex Corporation
- Quantity
- 296 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
- Recall date
- July 13, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)