United StatesAniara Diagnostica LLC is recalling three 5‑PLASMA Bivalirudin products: the AMR Verification Kit (Model 5D‑45905, Lot KE132603, UDI‑DI 05070002420378), the Calibrator (Model 5D‑46905, Lot KE132601, UDI‑DI 05070002420392), and the Control (Model 5D‑44905, Lot KE132602, UDI‑DI 05070002420385) distributed in IL, NC, and TN. The recall was issued because stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix can cause degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
What's being recalled
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Recalling firm: Aniara Diagnostica LLC, West Chester, OH, United States.
How to identify it
UDI-DI: 05070002420378, Lot Number: KE132603 UDI-DI: 05070002420392, Lot Number: KE132601 UDI-DI: 05070002420385, Lot Number: KE132602
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of IL, NC, TN.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)