Device recall: 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
Class II FDA enforcement event 99344. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Aniara Diagnostica LLC started this device recall on 1 Jul 2026. The firm address in the FDA record is in West Chester, OH. FDA put the recall in Class II. FDA event 99344 has 3 product records. The first FDA enforcement report date is 12 Aug 2026. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution in the states of IL, NC, TN.
Recalling firm
Aniara Diagnostica LLC, West Chester, OH.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2894-2026 | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | 4 units | Class II | Ongoing | 12 Aug 2026 |
| Z-2895-2026 | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 | 7 units | Class II | Ongoing | 12 Aug 2026 |
| Z-2896-2026 | 5-PLASMA Bivalirudin Control, Model Number 5D-44905 | 9 units | Class II | Ongoing | 12 Aug 2026 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2026
- 572
- Share of these events in Class II
- 87%
- Product records in this event
- 3Median of the firm: 2
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Apr 2026 | ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A | Device | Class II | 1 |
| 1 Feb 2023 | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Prote | Device | Class II | 1 |
| 28 Jun 2022 | BIOPHEN UFH Control Plasma | Device | Class III | 1 |
| 19 Jul 2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | Device | Class II | 2 |
| 19 Mar 2019 | BIOPHEN UFH Control C2, REF 223901 | Device | Class III | 3 |
Official channels
- FDA enforcement report Z-2894-2026The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 99344. https://recallregister.com/fda/ii/99344/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution in the states of IL, NC, TN.
- What quantity of product is in FDA event 99344?
- The event has 3 product records. The first record gives this quantity:
4 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2026 have the same class?
- 87% of the 572 device events that started in 2026 are in Class II.