CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Zymutest Hia IgG, in vitro diagnostic Elisa kit recalled
Aniara Diagnostica is recalling Zymutest Hia IgG, in vitro diagnostic Elisa kit, distributed nationwide in the US. The recall was initiated on 1 Apr 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2171-2026
- FDA event ID
- 98754
- Recalling firm
- Aniara Diagnostica, West Chester, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Apr 2026
- FDA classified
- 12 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Apr 2026 | Recall initiated by company | |
| 12 May 2026 | Classified by FDA | +41 days |
| 20 May 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Where it was distributed
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Nationwide CaliforniaGeorgiaMinnesotaMissouriNorth CarolinaNew MexicoNew YorkVirginiaWashingtonWisconsin
Questions about this recall
Why was it 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Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Which lots are affected?
UDI-DI: 03663537018763; Lot Number: FD1265
Where was it sold?
US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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