Aniara Diagnostica LLC recalls
Every recall we track for Aniara Diagnostica LLC — 11 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Aniara Diagnostica LLC peaked in 2019 (5); 11 since 2017.
All FDA recall records for Aniara Diagnostica LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 5 | 0 | 5 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 4 | 0 | 4 |
What to do if you have a recalled Aniara Diagnostica LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Aniara Diagnostica LLC recalls
6 shown- Lower riskMedical device
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Control, Model Number 5D-44905
Aniara Diagnostica recalls 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues causing degraded bivalirudin measurements. Affected units have UDI-DI: 05070002420385 and Lot Number KE132602.
Aniara DiagnosticaJul 1, 2026 - Lower riskMedical device
Aniara Diagnostica LLC recalls ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Aniara Diagnostica recalls ZYMUTEST HIA IgG ELISA kits with lot number FD1265 due to outdated positive control values in the test instructions.
Aniara DiagnosticaApr 1, 2026 - Lower riskMedical device
Aniara Diagnostica LLC recalls BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma.
Aniara Diagnostica recalls BIOPHEN Protein C 5 kits due to Cesium Chloride in Reagent 2 being classified as hazardous under CLP regulations, suspected of damaging fertility. Affected kits have UDI-DI: 366353700063BD Lot FA083327 and all future lots.
Aniara DiagnosticaFeb 1, 2023 - Lower riskMedical device
Aniara Diagnostica LLC recalls BIOPHEN UFH Control Plasma
Aniara Diagnostica recalls BIOPHEN UFH Control Plasma due to incorrect product labeling in the package. This may cause confusion with similar products.
Aniara DiagnosticaJun 28, 2022 - Lower riskMedical device
Aniara Diagnostica LLC recalls ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Aniara Diagnostica recalls ZYMUTEST HIA MonoStrip IgG ELISA kits (Model RK041A) due to residual crystallization causing negative controls to go out of range. Affected kits sold under specific serial numbers.
Aniara DiagnosticaJul 19, 2019 - Lower riskMedical device
Aniara Diagnostica LLC recalls BIOPHEN UFH Control C1, REF 224101
Aniara Diagnostica recalls BIOPHEN UFH Control C1 devices with specific lot numbers due to incorrect Instructions for Use packaging. Affected units may have improper instructions that could lead to improper use.
Aniara DiagnosticaMar 19, 2019
Aniara Diagnostica LLC recall questions
How many recalls has Aniara Diagnostica LLC had?
11 recalls from Aniara Diagnostica LLC are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Aniara Diagnostica LLC recall?
Aniara Diagnostica LLC recalls 5-PLASMA Bivalirudin Control, Model Number 5D-44905, dated Jul 1, 2026. Every Aniara Diagnostica LLC recall is listed on this page, newest first.
What should I do if I have a recalled Aniara Diagnostica LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Aniara Diagnostica LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.