ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Quick Facts at a Glance
- Recall Date
- April 1, 2026
- Hazard Level
- HIGH
- Brand
- Aniara Diagnostica
- Geographic Scope
- 1 states
Hazard Information
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aniara Diagnostica LLC or your healthcare provider for instructions. Notification method: Letter
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Full Description
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 Reason: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.. Classification: Class II. Quantity: 359 units. Distribution: US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
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