Summary
The FDA issued a Class III for BIOPHEN UFH Control Plasma by Aniara Diagnostica LLC. Reason: Incorrect product labeling was included in the package..
Details
Source
Device Recall
External ID
Z-1743-2022
Action Date
2022-09-21
Status
Terminated
Category
device
Product Description
BIOPHEN UFH Control Plasma
Lot/Code Info: UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035
Quantity Affected: 13 units (1 unit is 1 box)
Reason for Recall
Incorrect product labeling was included in the package.
Distribution
Distribution in US - IL and MI
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-28
Company
West Chester, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aniara Diagnostica LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aniara Diagnostica LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aniara Diagnostica LLC have FDA actions?
Aniara Diagnostica LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1743-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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