ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Reported: August 28, 2019 Initiated: July 19, 2019 #Z-2346-2019
Product Description
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Reason for Recall
Residual crystallization of the microplate and recurrent negative controls out of range.
Details
- Recalling Firm
- Aniara Diagnostica LLC
- Units Affected
- 51
- Distribution
- Distribution to US states of NC, NH, NY, and OH, and Sweden.
- Location
- West Chester, OH
Frequently Asked Questions
What product was recalled? ▼
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.. Recalled by Aniara Diagnostica LLC. Units affected: 51.
Why was this product recalled? ▼
Residual crystallization of the microplate and recurrent negative controls out of range.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Moderate. Recall number: Z-2346-2019.
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