Aniara 5-PLASMA Bivalirudin Control recalled for stability issues
Aniara Diagnostica LLC is recalling 9 units of its 5-PLASMA Bivalirudin Control, model 5D-44905, lot KE132602. The agency reports stability issues with the reconstituted plasma and bivalirudin matrix, which degrade measurable bivalirudin in the controls, calibrators and linearity values. The product was distributed in the US in IL, NC and TN.
From the FDA notice · Read the official notice ↗
What to do
- Set aside lot KE132602 and do not use it for testing or calibration.
- Confirm the product by checking model 5D-44905 and UDI-DI 05070002420385 on the label.
- The notice does not state a remedy; contact Aniara Diagnostica LLC for next steps.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 9 units
- Illnesses reported
- None reported
- Manufactured in
- 7768 Service Center Dr, West Chester, OH, United States
- Classification
- Class II
- Recall number
- Z-2896-2026
In the FDA's words
- Description
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905 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: 05070002420385, Lot Number: KE132602 Distribution: US Nationwide distribution in the states of IL, NC, TN. Affected quantity: 9 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-46905Z-2895-2026 · 7 units
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905 (this page)Z-2896-2026 · 9 units