BIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard
The BIOPHEN Protein C 5 reagent kit from Aniara Diagnostica contains Cesium Chloride in Reagent 2, suspected of damaging fertility. The manufacturer is issuing updated product labeling with warnings about this regulatory classification change.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The hazard is based on a regulatory classification change for Cesium Chloride (suspected of damaging fertility) rather than confirmed harm. The recall is a precautionary labeling update.
Plain-English summary
Aniara Diagnostica LLC is issuing updated labeling for the BIOPHEN Protein C 5 kit, lot FA083327 and all future lots. This is an in vitro diagnostic test used to quantitatively measure Protein C activity in human blood plasma.
Reagent 2 (R2) in the BIOPHEN Protein C 5 kit contains Cesium Chloride. This chemical has changed regulatory classification under CLP regulation (EC) No 1272/2008 and is now classified as hazardous. Specifically, Cesium Chloride is suspected of damaging fertility.
The affected kits were distributed nationwide in the United States. Aniara Diagnostica is updating the product labeling to include new warnings and precautionary statements regarding the Cesium Chloride hazard classification.
Healthcare professionals and laboratory personnel using this test kit should review the updated product labeling for the new safety warnings regarding Cesium Chloride in Reagent 2.
The recalled product
- Product
- BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac…
- Manufacturer
- Aniara Diagnostica LLC
- Affected units
- 2
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 (1)
- UDI-DI: 366353700063BD Lot FA083327 (And all future lots)
Distribution
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