Aniara Diagnostica Recalls 5-PLASMA Bivalirudin AMR Verification Kit
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Aniara Diagnostica LLC is recalling 4 units of the 5-PLASMA Bivalirudin AMR Verification Kit due to stability issues affecting the product.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references Illinois, North Carolina, Tennessee. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Aniara Diagnostica LLC has initiated a recall due to stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix. These issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Which Products Are Affected
The recall affects the 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905. Affected units have UDI-DI 05070002420378 and Lot Number KE132603. A total of 4 units were distributed nationwide in the states of IL, NC, and TN.
What You Should Do
Consumers should contact Aniara Diagnostica LLC regarding the recalled product. The recall was initiated voluntarily by the firm via letter.
Why This Matters
The recall involves a Class II medical device distributed to three U.S. states and is classified as ongoing by the FDA.
Source
FDA recall number Z-2894-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (885 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 19, 2026.
Frequently Asked Questions
Common questions about this FDA recall.