West Chester, OH, United States
Aniara Diagnostica LLC recalls
6 recalls recorded since 2018, most recently on 1 July 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)3
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 July 2026
- Reason
- 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.
- Distribution
- US Nationwide distribution in the states of IL, NC, TN.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2894-2026, Z-2895-2026, Z-2896-2026
- 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905
- 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
- 5-PLASMA Bivalirudin Control, Model Number 5D-44905
Ongoing Class II Medical devices
- Recall started
- 1 April 2026
- Reason
- Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2171-2026
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Ongoing Class II Medical devices
- Recall started
- 1 February 2023
- Reason
- 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
- Distribution
- US Nationwide distribution in the state of NC.
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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 meas
Terminated Class III Medical devices
- Recall started
- 28 June 2022
- Terminated
- 18 April 2024
- Reason
- Incorrect product labeling was included in the package.
- Distribution
- Distribution in US - IL and MI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1743-2022
- BIOPHEN UFH Control Plasma
Terminated Class II Medical devices
- Recall started
- 19 July 2019
- Terminated
- 11 June 2021
- Reason
- Residual crystallization of the microplate and recurrent negative controls out of range.
- Distribution
- Distribution to US states of NC, NH, NY, and OH, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2346-2019, Z-2347-2019
- ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
- ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
Terminated Class III Medical devices
- Recall started
- 19 March 2019
- Terminated
- 12 July 2019
- Reason
- The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
- Distribution
- Distributed to accounts in MI and PA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1189-2019, Z-1190-2019, Z-1188-2019
- BIOPHEN UFH Control C1, REF 224101
- BIOPHEN LMWH Control C4, REF 224201
- BIOPHEN UFH Control C2, REF 223901
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.