Food, drugs, devices › Aniara Diagnostica LLC
Device recall: ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
FDA enforcement event 83487 is a device recall by Aniara Diagnostica LLC of West Chester, OH, initiated 19 Jul 2019 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 11 Jun 2021. Initiation: voluntary: firm initiated. Aniara Diagnostica LLC has 6 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aniara Diagnostica LLC, West Chester, OH.
Reason for recall
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2346-2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | 51 | Class II | Terminated | 28 Aug 2019 |
| Z-2347-2019 | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. | 46 | Class II | Terminated | 28 Aug 2019 |
Context
Other enforcement events for Aniara Diagnostica LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Jul 2026 | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 | Device | Class II | 3 |
| 1 Apr 2026 | ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A | Device | Class II | 1 |
| 1 Feb 2023 | BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Prote | Device | Class II | 1 |
| 28 Jun 2022 | BIOPHEN UFH Control Plasma | Device | Class III | 1 |
| 19 Mar 2019 | BIOPHEN UFH Control C2, REF 223901 | Device | Class III | 3 |
All 6 events for Aniara Diagnostica LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Residual crystallization of the microplate and recurrent negative controls out of range."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Distribution to US states of NC, NH, NY, and OH, and Sweden."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Jun 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.