V8 Immunodisplacement Kit recall: Contamination
V8 Immunodisplacement Kit REF 1803
Why was V8 Immunodisplacement Kit recalled?
Due to microbial growth causing interference with interpretation.
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?
Model Number: 1803 UDI Codes: +M52518030/SS73-21-1803/14D20230831Z +M52518030/SS71-21-1803/14D20230830X Lot 3-21-1803 Lot 1-22-1803
- Product
- V8 Immunodisplacement Kit REF 1803
- Recalling firm
- Helena Laboratories, Corp.
- Quantity
- 51 kits
- Distribution
- U.S.: FL, MO, OH, and TX O.U.S.: Canada, Uruguay, and Vietnam,
- Recall date
- June 15, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)