FDA recall, , Moderate risk
ZYMUTEST HIA IgG, in Vitro Diagnostic ELISA Kit
The ZYMUTEST HIA IgG kit may have incorrect values for the positive control.
Summary by Recall Canary from the FDA notice
What happened
Aniara Diagnostica LLC of West Chester, Ohio, recalled the Zymutest HIA IgG, an in vitro diagnostic ELISA kit, Ref. RK040A, because kits from a certain lot had been packaged on 17 October 2024 and put on the market with an outdated flyer dated 8 October 2024, containing incorrect values for the positive control. The recall began April 1, 2026, and was added to the FDA's Enforcement Report on May 12, 2026.
The recalled kits were distributed in California, Georgia, Minnesota, Missouri, North Carolina, New Mexico, New York, Virginia, Washington, and Wisconsin. The company recalled 359 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your kit affected?
Match the lot code and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Zymutest HIA IgG, in vitro diagnostic ELISA kit
- UDI-DI
- 03663537018763
- Lot code
- FD1265
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Georgia, Minnesota, Missouri, North Carolina, New Mexico, New York, Virginia, Washington, and Wisconsin
- Company
- Aniara Diagnostica LLCWest Chester, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98754
- Recall number
- Z-2171-2026
- Quantity recalled
- 359 units
All recalls from Aniara Diagnostica LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
