CLASS II Device recall · Reported 28 Aug 2019 · FDA Enforcement Report
Zymutest Hia MonoStrip, IgG Elisa kit recalled by Aniara Diagnostica
Aniara Diagnostica is recalling Zymutest Hia MonoStrip, IgG Elisa kit, distributed in North Carolina, New Hampshire, New York, Ohio. The recall was initiated on 19 Jul 2019 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-2346-2019
- FDA event ID
- 83487
- Recalling firm
- Aniara Diagnostica, West Chester, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jul 2019
- FDA classified
- 22 Aug 2019
- Reported
- 28 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 19 Jul 2019 | Recall initiated by company | |
| 22 Aug 2019 | Classified by FDA | +34 days |
| 28 Aug 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Residual crystallization of the microplate and recurrent negative controls out of range.
Product as listed by the FDA
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Where it was distributed
Distribution to US states of NC, NH, NY, and OH, and Sweden.
Questions about this recall
Why was it recalled?
Residual crystallization of the microplate and recurrent negative controls out of range.
Which lots are affected?
F1701084, F1900611
Where was it sold?
Distribution to US states of NC, NH, NY, and OH, and Sweden.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83487| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Zymutest Hia MonoStrip, IgGAM Elisa kit recalled by Aniara Diagnostica | Aniara Diagnostica | Other | 4 states |
More recalls from Aniara Diagnostica
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 5-Plasma Bivalirudin Control recalled by Aniara Diagnostica | Aniara Diagnostica | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | 5-Plasma Bivalirudin Calibrator recalled by Aniara Diagnostica | Aniara Diagnostica | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | 5-Plasma Bivalirudin AMR Verification Kit recalled by Aniara Diagnostica | Aniara Diagnostica | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Zymutest Hia IgG, in vitro diagnostic Elisa kit recalled | Aniara Diagnostica | Packaging Defects | Nationwide |
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