Aniara Diagnostica LLC
FDA Regulatory Profile
Aniara Diagnostica LLC appears in FDA public data with 11 recalls, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2895-2026, Class II) was initiated on Jul 1, 2026. Its most recent 510(k) clearance was granted on May 8, 2009.
Summary
- Total Recalls
- 11
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2895-2026 | Class II | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 | Jul 1, 2026 |
| Z-2894-2026 | Class II | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | Jul 1, 2026 |
| Z-2896-2026 | Class II | 5-PLASMA Bivalirudin Control, Model Number 5D-44905 | Jul 1, 2026 |
| Z-2171-2026 | Class II | ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A | Apr 1, 2026 |
| Z-1227-2023 | Class II | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human ci | Feb 1, 2023 |
| Z-1743-2022 | Class III | BIOPHEN UFH Control Plasma | Jun 28, 2022 |
| Z-2346-2019 | Class II | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | Jul 19, 2019 |
| Z-2347-2019 | Class II | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. | Jul 19, 2019 |
| Z-1188-2019 | Class III | BIOPHEN UFH Control C2, REF 223901 | Mar 19, 2019 |
| Z-1189-2019 | Class III | BIOPHEN UFH Control C1, REF 224101 | Mar 19, 2019 |
| Z-1190-2019 | Class III | BIOPHEN LMWH Control C4, REF 224201 | Mar 19, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K083729 | HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL | May 8, 2009 |