BIOPHEN UFH Control C1 recall
BIOPHEN UFH Control C1, REF 224101
Why was BIOPHEN UFH Control C1 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?
Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1
- Product
- BIOPHEN UFH Control C1, REF 224101
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 41 units
- Distribution
- Distributed to accounts in MI and PA.
- Recall date
- April 24, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)