Aniara 5-PLASMA Bivalirudin Calibrator recalled for stability issues
Aniara Diagnostica LLC is recalling its 5-PLASMA Bivalirudin Calibrator, model 5D-46905, because stability issues have been identified with the reconstituted lyophilized human plasma and bivalirudin matrix. These issues cause measurable bivalirudin to degrade in the controls, calibrators and linearity values. The product was distributed nationwide, with the listed states being Illinois, North Carolina and Tennessee.
From the FDA notice · Read the official notice ↗
What to do
- Set aside lot KE132601 (UDI-DI 05070002420392) and do not use it for calibration or testing.
- The notice doesn't say how to get a refund or replacement; contact Aniara Diagnostica LLC or where you bought it.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 3 products — see all of them.
Details
- Units affected
- 7 units
- Illnesses reported
- None reported
- Manufactured in
- 7768 Service Center Dr, West Chester, OH, United States
- Classification
- Class II
- Recall number
- Z-2895-2026
In the FDA's words
- Description
- 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 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: 05070002420392, Lot Number: KE132601 Distribution: US Nationwide distribution in the states of IL, NC, TN. Affected quantity: 7 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-45905Z-2894-2026 · 4 units
- 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 (this page)Z-2895-2026 · 7 units
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905Z-2896-2026 · 9 units