Aniara Diagnostica Recalls 5-PLASMA Bivalirudin Calibrator
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Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator (Model 5D-46905) due to stability issues causing degradation of bivalirudin.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 19, 2026 and geographically references United States. 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 degradation of measurable bivalirudin in the controls, calibrators, and linearity values.
Which Products Are Affected
The recall involves 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905. Affected details include UDI-DI: 05070002420392 and Lot Number: KE132601. A total of 7 units were distributed nationwide in the states of IL, NC, and TN.
What You Should Do
Consumers in possession of the recalled product should follow instructions provided by the recalling firm.
Why This Matters
This Class II recall addresses a defect that may cause temporary or reversible adverse health consequences.
Source
FDA recall number Z-2895-2026, report date 20260812.
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 (854 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.