ZYMUTEST HIA MonoStrip recall
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Why was ZYMUTEST HIA MonoStrip recalled?
Residual crystallization of the microplate and recurrent negative controls out of range.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
F1701084, F1900611
- Product
- ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 51
- Distribution
- Distribution to US states of NC, NH, NY, and OH, and Sweden.
- Recall date
- August 28, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)