medical MODERATE Updated 2026-08-12

Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

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Recalled Product

5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 05070002420392, Lot Number: KE132601

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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