BIOPHEN UFH Control Plasma Includes Incorrect Product Labeling in Package
BIOPHEN UFH Control Plasma boxes contain incorrect product labeling. Aniara Diagnostica LLC is recalling 13 units (Lot FA2035) distributed in Illinois and Michigan.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for incorrect product labeling with no reported illnesses or injuries. Per the severity rubric, packaging and documentation errors are classified as Low severity.
Plain-English summary
Aniara Diagnostica LLC is recalling BIOPHEN UFH Control Plasma because the product packages include incorrect labeling. Thirteen units with Lot Code FA2035 were distributed in Illinois and Michigan.
BIOPHEN UFH Control Plasma is a quality control reagent used in clinical laboratory diagnostic testing. Incorrect labeling on the package may cause confusion about product identity or contents.
If you have received this product, contact Aniara Diagnostica LLC or your healthcare provider for instructions on whether to return, replace, or discard the affected lot.
The recalled product
- Product
- BIOPHEN UFH Control Plasma
- Manufacturer
- Aniara Diagnostica LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI (GTIN): 03663537008290 Reference No.: 223101
- Lot Code: FA2035
Distribution
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