Aniara 5-PLASMA Bivalirudin kit recalled for stability issues
Aniara Diagnostica LLC is recalling its 5-PLASMA Bivalirudin AMR Verification Kit because stability issues were found with the reconstituted lyophilized human plasma and bivalirudin matrix. These issues cause measurable bivalirudin to degrade in the controls, calibrators, and linearity values. The kit was distributed in IL, NC, and TN, with no injuries reported.
From the FDA notice · Read the official notice ↗
What to do
- Set aside and stop using affected lot KE132603 (model 5D-45905, UDI-DI 05070002420378) for testing.
- The notice doesn't state a remedy; contact Aniara Diagnostica LLC for instructions on returning or replacing the kit.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 4 units
- Illnesses reported
- None reported
- Manufactured in
- 7768 Service Center Dr, West Chester, OH, United States
- Classification
- Class II
- Recall number
- Z-2894-2026
In the FDA's words
- Description
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 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. UDI-DI: 05070002420378, Lot Number: KE132603 Distribution: US Nationwide distribution in the states of IL, NC, TN. Affected quantity: 4 units
- 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.
3 products in this recall
The agency lists each product separately. Check every one you might have.
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 (this page)Z-2894-2026 · 4 units
- 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Z-2895-2026 · 7 units
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905Z-2896-2026 · 9 units