Aniara Diagnostica recalls 5-PLASMA Bivalirudin AMR Verification Kit (Model 5D-45905) due to stability problems causing inaccurate test results. Affected units may need replacement.
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 a specific blood test kit because it may not work properly over time. This could lead to inaccurate test results, which might affect medical decisions.
The kit's reconstituted plasma and bivalirudin matrix degrade over time, leading to less accurate test results. This could cause incorrect medical decisions if the test is used without proper calibration.
Healthcare professionals using this kit for blood tests are most likely affected. Patients using the kit for diagnostic purposes may also be impacted if results are inaccurate.
Check for the model number 5D-45905 on the kit. The kit was sold with UDI-DI: 05070002420378 and Lot Number: KE132603.
Look for the model number 5D-45905 and UDI-DI: 05070002420378 on the kit packaging.
The recall is due to potential inaccurate test results, not immediate safety risks. The kit is safe to use but may not work properly over time.
Check for the model number 5D-45905 and UDI-DI: 05070002420378 on the kit packaging.
The recall does not specify a remedy, so contact Aniara Diagnostica for guidance on next steps.
We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.
Subject: Recall Z-2894-2026 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-2894-2026 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.
