FDA recall, , Moderate risk
Aniara Diagnostica 5-PLASMA Bivalirudin Kits, Calibrators and Controls
The 5-Plasma Bivalirudin AMR Verification Kit has stability issues that degrade measurable bivalirudin.
Summary by Recall Canary from the FDA notice
What happened
Aniara Diagnostica LLC of West Chester, Ohio recalled its 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905, along with the 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905, and the 5-PLASMA Bivalirudin Control, Model Number 5D-44905.
The recall began July 1, 2026, and was added to the FDA's Enforcement Report on August 5, 2026, with distribution in Illinois, North Carolina, and Tennessee. Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix cause degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
3 products
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- UDI-DI
- 05070002420378
- Lot code
- KE132603
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
- UDI-DI
- 05070002420392
- Lot code
- KE132601
5-PLASMA Bivalirudin Control, Model Number 5D-44905
- UDI-DI
- 05070002420385
- Lot code
- KE132602
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Illinois, North Carolina, Tennessee.
- Company
- Aniara Diagnostica LLCWest Chester, Ohio
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99344
- Recall numbers
- Z-2894-2026 to Z-2896-2026
All recalls from Aniara Diagnostica LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
