BIOPHEN UFH Control C2 recall
BIOPHEN UFH Control C2, REF 223901
Why was BIOPHEN UFH Control C2 recalled?
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Lot F1700315P7
- Product
- BIOPHEN UFH Control C2, REF 223901
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 14 kits
- Distribution
- Distributed to accounts in MI and PA.
- Recall date
- April 24, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)