ZYMUTEST HIA IgG recall (Aniara Diagnostica LLC)
Medical deviceClass IIOngoing
Summary: Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A. Reason: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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 is being recalled
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Why
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI (states named: California, Georgia, Minnesota, Missouri, North Carolina, New Mexico, New York, Virginia, Washington, Wisconsin)
How to tell if yours is affected
UDI-DI: 03663537018763; Lot Number: FD1265
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2171-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 1, 2026 |
| Reported | May 20, 2026 |
| Company | Aniara Diagnostica LLC |
| Company location | West Chester, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 359 units |
More recalls from Aniara Diagnostica LLC · all medical device recalls · recalls from April 2026