Aniara Diagnostica LLC
Aniara Diagnostica LLC has 6 FDA enforcement events on this register (11 product records) between 2019 and 2026: 6 device; the busiest year was 2019 with 2.
0% of its events are Class I; the most common class is Class II (4). 3 events are listed as ongoing; the recalling firm's address is in OH.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 1 Jul 2026 | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | Device | Class II | 3 | Ongoing |
| 1 Apr 2026 | ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A | Device | Class II | 1 | Ongoing |
| 1 Feb 2023 | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted… | Device | Class II | 1 | Ongoing |
| 28 Jun 2022 | BIOPHEN UFH Control Plasma | Device | Class III | 1 | Terminated |
| 19 Jul 2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | Device | Class II | 2 | Terminated |
| 19 Mar 2019 | BIOPHEN UFH Control C2, REF 223901 | Device | Class III | 3 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Aniara Diagnostica LLC had?
6 enforcement events (11 product records) on this register, 2019–2026: 6 device.
Are any Aniara Diagnostica LLC recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are Aniara Diagnostica LLC recalls?
4 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.