ZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values
Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.
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: This is an FDA Class II recall with a labeling/documentation error (incorrect control values in the flyer). The hazard is potential misinterpretation of test results due to incorrect reference documentation; no illnesses or injuries are reported, and the issue is correctible through updated documentation.
Plain-English summary
Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG in vitro diagnostic ELISA kits (Reference RK040A, Lot FD1265) distributed nationwide in California, Georgia, Minnesota, Missouri, North Carolina, New Mexico, New York, Virginia, Washington, and Wisconsin. A total of 359 units were packaged on October 17, 2024, and distributed with an outdated product flyer dated October 8, 2024.
The flyer included in the kits contained incorrect values for the positive control. Inaccurate control values in diagnostic test documentation could lead to misinterpretation of test results if users rely on the incorrect reference values provided in the flyer.
Users of this kit should verify they have Lot FD1265 and check the accuracy of any control values used against the current, corrected documentation. Facilities should contact Aniara Diagnostica LLC for correct positive control values and updated documentation.
The recalled product
- Product
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Manufacturer
- Aniara Diagnostica LLC
- Affected units
- 359
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 (2)
- UDI-DI: 03663537018763
- Lot Number: FD1265
Distribution
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