Aniara Diagnostica Llc: Calibrator, Multi-analyte Mixture
Recall Summary Aniara Diagnostica LLC is recalling its 5-PLASMA Bivalirudin Calibrator (Model 5D-46905), a product used to calibrate blood testing equipment. The calibrator's reconstituted plasma mixture degrades over time, causing the bivalirudin measurement levels to decrease and potentially produce inaccurate test results. The product was distributed nationwide, with primary distribution in Illinois, North Carolina, and Tennessee.
- Recalling firm
- Aniara Diagnostica LLC
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-07-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/ecd62d59-9fea-48af-82ee-2994952b5d8f