Zymutest HIA Igg recall
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Why was Zymutest HIA Igg recalled?
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 03663537018763; Lot Number: FD1265
- Product
- ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 359 units
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
- Recall date
- May 20, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)