5-PLASMA Bivalirudin Control, Model Number 5D-44905
Aniara Diagnostica LLC
The hazard
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 05070002420385Model Lot Number: KE132602UPC 05070002420385Would you have heard about this one?
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