5-PLASMA Bivalirudin Calibrator recall (Aniara Diagnostica LLC)
Medical deviceClass IIOngoing
Summary: Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905. Reason: 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 is being recalled
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of IL, NC, TN. (states named: Illinois, North Carolina, Tennessee)
How to tell if yours is affected
UDI-DI: 05070002420392, Lot Number: KE132601
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2895-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 1, 2026 |
| Reported | August 12, 2026 |
| Company | Aniara Diagnostica LLC |
| Company location | West Chester, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 units |
More recalls from Aniara Diagnostica LLC · all medical device recalls · recalls from July 2026