Aniara Diagnostica LLC
West Chester, OH, US
ANIARA DIAGNOSTICA, LLC appears in FDA device records in West Chester, OH. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Aniara Diagnostica LLC in 2009.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005017664 | 3005017664 | ANIARA DIAGNOSTICA, LLC | 7768 Service Center Dr, West Chester, OH 45069 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2896-2026 | 5-PLASMA Bivalirudin Control, Model Number 5D-44905 | 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 | Open, Classified | |
| Z-2895-2026 | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 | 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 | Open, Classified | |
| Z-2894-2026 | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | 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 | Open, Classified | |
| Z-2171-2026 | ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A | Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. | Class II | Open, Classified | |
| Z-1227-2023 | 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 from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen. | 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 | Class II | Open, Classified | |
| Z-1743-2022 | BIOPHEN UFH Control Plasma | Incorrect product labeling was included in the package. | Class III | Terminated | |
| Z-2347-2019 | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. | Residual crystallization of the microplate and recurrent negative controls out of range. | Class II | Terminated | |
| Z-2346-2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | Residual crystallization of the microplate and recurrent negative controls out of range. | Class II | Terminated | |
| Z-1190-2019 | BIOPHEN LMWH Control C4, REF 224201 | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. | Class III | Terminated | |
| Z-1189-2019 | BIOPHEN UFH Control C1, REF 224101 | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. | Class III | Terminated | |
| Z-1188-2019 | BIOPHEN UFH Control C2, REF 223901 | The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. | Class III | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain