Aniara Diagnostica recalls 5-PLASMA Bivalirudin Calibrator Model 5D-46905 due to stability issues causing degraded bivalirudin measurements. Affected units have UDI-DI: 05070002420392 and Lot Number KE132601.
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.
Aniara Diagnostica is recalling its 5-PLASMA Bivalirudin Calibrator (Model 5D-46905) because stability problems may cause inaccurate bivalirudin measurements. This could affect lab results if the device is used without proper calibration.
The calibrator's reconstituted plasma and bivalirudin matrix degrade over time, leading to inaccurate measurements. This could cause lab results to be unreliable if the device is used without proper calibration.
Laboratory users who own or use the 5-PLASMA Bivalirudin Calibrator Model 5D-46905 with UDI-DI: 05070002420392 and Lot Number KE132601 are most at risk. This recall affects specific lab equipment used in medical testing.
Check for the model number 5D-46905 on the device. Affected units have UDI-DI: 05070002420392 and Lot Number KE132601.
Identify the model number and UDI-DI to confirm if your device is affected.
The recall is due to stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix, which can cause degraded bivalirudin measurements.
Check the model number and UDI-DI to see if your device is affected. No specific action is required beyond verification.
The recall record does not mention any remedy or fix for this issue.
We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.
Subject: Recall Z-2895-2026 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-2895-2026 from Aniara Diagnostica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
