Aniara Diagnostica Recalls ZYMUTEST HIA MonoStrip ELISA Kits
Aniara Diagnostica LLC is recalling 46 units of ZYMUTEST HIA MonoStrip ELISA kits due to residual crystallization and out-of-range negative controls.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Aniara Diagnostica LLC is recalling 46 units of the ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D. The product is intended for in vitro diagnostic use. The recall was initiated because of residual crystallization of the microplate and recurrent negative controls that were out of range.
The affected products were distributed to the US states of North Carolina, New Hampshire, New York, and Ohio, as well as to Sweden. The specific lot code for the recalled items is F1701571.
Consumers and healthcare facilities should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
- Manufacturer
- Aniara Diagnostica LLC
- Hazard
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- F1701571
Distribution
Part of a larger recall action
This product is one of 2 recalled by Aniara Diagnostica LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Aniara Diagnostica LLC
See all →- Moderate5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- ModerateAniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues
FDA (Devices) · 2026-08-12
- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- ModerateZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values
FDA (Devices) · 2026-05-20
- ModerateBIOPHEN Protein C 5 Kit Labeling Update for Reproductive Hazard
FDA (Devices) · 2023-03-15
Same hazard · quality defect
See all →- LowSupernus Recalls Trokendi XR Topiramate Capsules for Dissolution Failure
FDA (Drugs) · 2026-09-09
- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMedline Circumcision Trays recalled due to Lidocaine quality issues
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
Similar recalls
- ModerateZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values
FDA (Devices) · 2026-05-20
- ModerateHyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Risk
FDA (Devices) · 2018-03-21
- ModerateHyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Results
FDA (Devices) · 2018-03-21
- ModerateHyphen BioMed Recalls ZYMUTEST HIA MonoStrip IgG Assay Kits
FDA (Devices) · 2018-05-16
- ModerateHyphen BioMed Recalls ZYMUTEST HIA MonoStria Assay Due to Labeling Error
FDA (Devices) · 2018-05-16
- ModerateEuro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation
FDA (Devices) · 2018-01-10