Aniara Diagnostica recalls 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues causing degraded bivalirudin measurements. Affected units have UDI-DI: 05070002420385 and Lot Number KE132602.
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 Control (Model 5D-44905) because stability problems can cause inaccurate bivalirudin measurements. This affects lab testing accuracy and could lead to incorrect results if used without proper calibration.
The reconstituted plasma and bivalirudin matrix degrade over time, leading to lower measurable bivalirudin levels. This can cause inaccurate lab results for certain tests, potentially affecting patient care decisions.
Laboratory users who purchased or use the 5-PLASMA Bivalirudin Control (Model 5D-44905) with UDI-DI: 05070002420385 and Lot Number KE132602 are most at risk. This recall impacts clinical testing accuracy.
Check for the model number 5D-44905 on the product label. The specific UDI-DI code is 05070002420385 and lot number KE132602.
Verify the model number 5D-44905, UDI-DI code 05070002420385, and lot number KE132602 on the product.
The recall is due to stability issues that cause degraded bivalirudin measurements, which can lead to inaccurate lab results.
The official notice does not specify a remedy, so check with Aniara Diagnostica for further instructions.
Look for the model number 5D-44905, UDI-DI code 05070002420385, and lot number KE132602 on the product label.
We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.
Subject: Recall Z-2896-2026 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-2896-2026 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.
