FDA (Devices) recall action 99344
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Aniara Diagnostica LLC recalls its 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues causing degradation of measurable bivalirudin in controls, calibrators, and linearity values. FDA Class II recall.
Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.