Aniara Diagnostica, LLC
Country not established
- Devices
- 1
- FDA recalls
- 115 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Aniara Diagnostica, LLC makes
Aniara Diagnostica, LLC produces in vitro diagnostic reagents for coagulation testing, including calibrators and control plasmas used in laboratory analysis of blood clotting factors such as Factor V and activated protein C resistance.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 11 recalls initiated by Aniara Diagnostica, LLC, the earliest on 2019-03-19 and the most recent on 2026-07-01. By recorded status: 5 ongoing and 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 5
- 2020 0
- 2021 0
- 2022 1
- 2023 1
- 2024 0
- 2025 0
- 2026 4
2026
- 1 Jul 2026 Z-2894-2026 Class II Ongoing 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.
- 1 Jul 2026 Z-2895-2026 Class II Ongoing 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.
- 1 Jul 2026 Z-2896-2026 Class II Ongoing 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.
- 1 Apr 2026 Z-2171-2026 Class II Ongoing Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
2023
- 1 Feb 2023 Z-1227-2023 Class II Ongoing New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility
2022
- 28 Jun 2022 Z-1743-2022 Class III Terminated Incorrect product labeling was included in the package.
2019
- 19 Jul 2019 Z-2346-2019 Class II Terminated Residual crystallization of the microplate and recurrent negative controls out of range.
- 19 Jul 2019 Z-2347-2019 Class II Terminated Residual crystallization of the microplate and recurrent negative controls out of range.
- 19 Mar 2019 Z-1188-2019 Class III Terminated The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- 19 Mar 2019 Z-1189-2019 Class III Terminated The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Show all 11 recalls
2019
- 19 Mar 2019 Z-1190-2019 Class III Terminated The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Frequently asked questions
How many devices does Aniara Diagnostica, LLC have in the registry?
The registry currently lists 1 device for Aniara Diagnostica, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Aniara Diagnostica, LLC's devices?
Among its 1 most recently registered device, Aniara Diagnostica, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Aniara Diagnostica, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Aniara Diagnostica, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Aniara Diagnostica, LLC?
FDA recall records list 11 recalls initiated by Aniara Diagnostica, LLC, the most recent initiated on 1 Jul 2026. 5 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Aniara Diagnostica, LLC in the registry?
The most recently registered devices listed for Aniara Diagnostica, LLC include HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN.