Z-2171-2026 Class II Ongoing
FDA device recall Z-2171-2026 was initiated by Aniara Diagnostica LLC on April 1, 2026 and is designated Class II. Reason for recall: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. The recall status is ongoing. Affected quantity: 359 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- April 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 359 units
Product Description
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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 Pattern
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Code Information
UDI-DI: 03663537018763; Lot Number: FD1265