Lower riskMedical device recall · FDA · Published July 1, 2026
Aniara Diagnostica 5-PLASMA Bivalirudin Control Recall: Stability Issues
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 5-PLASMA Bivalirudin Control Recall: Stability Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/314291-aniara-diagnostica-5-plasma-bivalirudin-control-recall-stability-issues. Based on FDA recall #Z-2896-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2896-2026%22&limit=1).
Aniara Diagnostica LLC voluntarily recalled 9 units of 5-PLASMA Bivalirudin Control, Model Number 5D-44905, due to stability issues causing degradation of measurable bivalirudin. The Food and Drug Administration announced the Class II recall on July 1, 2026.
How to tell if you have it
Brand: Aniara Diagnostica
Product: 5-PLASMA Bivalirudin Control
Model Number: 5D-44905
Lot Number: KE132602
UDI-DI: 05070002420385
The hazard
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.
Context
GovInfoNow's records show Aniara Diagnostica LLC has 5 other recalls on record since March 19, 2019. Other recent recalls include the April 1, 2026 ZYMUTEST HIA IgG Kit Recall for incorrect positive control values and the Feb. 1, 2023 BIOPHEN Protein C 5 Kit Recall regarding cesium chloride hazards. Similar product recalls in December 2025 involved Fujirebio Lumipulse plasma controls and calibrators reporting inaccurate Alzheimer's test results.
How to tell if you have this one
Check for the model number 5D-44905 on the product label. The specific UDI-DI code is 05070002420385 and lot number KE132602.
Brand
Aniara Diagnostica
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of IL, NC, TN.
Recall number
Product, codes & lots
Quantity
Z-2894-2026
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905; UDI-DI: 05070002420378, Lot Number: KE132603
4 units
Z-2895-2026
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905; UDI-DI: 05070002420392, Lot Number: KE132601
7 units
Z-2896-2026
5-PLASMA Bivalirudin Control, Model Number 5D-44905; UDI-DI: 05070002420385, Lot Number: KE132602
9 units
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the model number 5D-44905, UDI-DI code 05070002420385, and lot number KE132602 on the product.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of IL, NC, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, North Carolina, Tennessee.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2896-2026 (July 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2896-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.