Aniara Diagnostica Llc: Calibrator, Secondary
Recall Summary Aniara Diagnostica LLC is recalling the 5-PLASMA Bivalirudin AMR Verification Kit (Model 5D-45905) because the reconstituted plasma and bivalirudin material degrades over time, causing inaccurate measurements of bivalirudin levels in the controls and calibrators. This is a Class II recall affecting medical laboratories nationwide that received this product. The company distributed the kits primarily in Illinois, North Carolina, and Tennessee, though they were also sent to other states.
- Recalling firm
- Aniara Diagnostica LLC
- Product
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- 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/8f203173-378a-457d-9097-64a6c939a668