Summary
The FDA issued a Class II for ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A by Aniara Diagnostica LLC. Reason: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values f.
Details
Source
Device Recall
External ID
Z-2171-2026
Action Date
2026-05-20
Status
Ongoing
Category
device
Product Description
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Lot/Code Info: UDI-DI: 03663537018763; Lot Number: FD1265
Quantity Affected: 359 units
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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-01
Company
West Chester, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aniara Diagnostica LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aniara Diagnostica LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aniara Diagnostica LLC have FDA actions?
Aniara Diagnostica LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2171-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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