FDAClass IIISeptember 21, 2022

BIOPHEN UFH Control Plasma recall: Labeling Error

BIOPHEN UFH Control Plasma

Why was BIOPHEN UFH Control Plasma recalled?

Incorrect product labeling was included in the package.

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?

UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035

Product
BIOPHEN UFH Control Plasma
Recalling firm
Aniara Diagnostica LLC
Quantity
13 units (1 unit is 1 box)
Distribution
Distribution in US - IL and MI
Recall date
September 21, 2022
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls