CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report
5-Plasma Bivalirudin AMR Verification Kit recalled by Aniara Diagnostica
Aniara Diagnostica is recalling 5-Plasma Bivalirudin AMR Verification Kit, distributed nationwide in the US. The recall was initiated on 1 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2894-2026
- FDA event ID
- 99344
- Recalling firm
- Aniara Diagnostica, West Chester, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Jul 2026
- FDA classified
- 5 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 1 Jul 2026 | Recall initiated by company | |
| 5 Aug 2026 | Classified by FDA | +35 days |
| 12 Aug 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Where it was distributed
US Nationwide distribution in the states of IL, NC, TN.
Questions about this recall
Why was it recalled?
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 lots are affected?
UDI-DI: 05070002420378, Lot Number: KE132603
Where was it sold?
US Nationwide distribution in the states of IL, NC, TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99344| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | 5-Plasma Bivalirudin Calibrator recalled by Aniara Diagnostica | Aniara Diagnostica | Potency & Assay | Nationwide | |
| CLASS II | 5-Plasma Bivalirudin Control recalled by Aniara Diagnostica | Aniara Diagnostica | Potency & Assay | Nationwide |
More recalls from Aniara Diagnostica
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5-Plasma Bivalirudin Control recalled by Aniara Diagnostica | Aniara Diagnostica | Potency & Assay | Nationwide |
| Device | CLASS II | 5-Plasma Bivalirudin Calibrator recalled by Aniara Diagnostica | Aniara Diagnostica | Potency & Assay | Nationwide |
| Device | CLASS II | Zymutest Hia IgG, in vitro diagnostic Elisa kit recalled | Aniara Diagnostica | Packaging Defects | Nationwide |
| Device | CLASS II | Biophen Protein C 5 kit recalled by Aniara Diagnostica | Aniara Diagnostica | Other | Nationwide |
| Device | CLASS III | Biophen UFH Control Plasma recalled by Aniara Diagnostica | Aniara Diagnostica | Packaging Defects | IL, MI |
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