- Recalling firm
- Aniara Diagnostica LLC
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- UDI-DI: 05070002420392, Lot Number: KE132601
- Units affected
- 7 units
- Distribution pattern
- US Nationwide distribution in the states of IL, NC, TN.
- Firm location
- West Chester, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2895-2026
- Recall initiated
- July 1, 2026
- FDA classification date
- August 5, 2026
- FDA report date
- August 12, 2026
- FDA event ID
- 99344
- Last updated on HTM Vibe
- August 18, 2026