Food, drugs, devices › Aniara Diagnostica LLC
Device recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Aniara Diagnostica LLC (West Chester, OH) initiated this device recall on 1 Apr 2026; FDA lists 1 product record under event 98754, classified Class II.
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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. 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
"Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control."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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2171-2026 | ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A | 359 units | Class II | Ongoing | 20 May 2026 |
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 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 Jul 2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. | Device | Class II | 2 |
| 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the reason for recall as: "Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control."
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: "US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI"
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.