Aniara Diagnostica Recalls 5-PLASMA Bivalirudin Control
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 9 units of 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues causing degradation of measurable bivalirudin.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 20, 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, MedicalDevices.
What Happened
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.
Which Products Are Affected
5-PLASMA Bivalirudin Control, Model Number 5D-44905. UDI-DI: 05070002420385, Lot Number: KE132602. 9 units distributed nationwide in the states of IL, NC, TN.
What You Should Do
The recall was initiated voluntarily by the firm via letter. Consumers with questions should contact the recalling firm.
Why This Matters
This is an ongoing FDA Class II recall affecting a small number of diagnostic control units distributed in three states.
Source
FDA recall number Z-2896-2026, initiated July 1, 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 (792 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 20, 2026.
Frequently Asked Questions
Common questions about this FDA recall.