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QUANTA Flash® h-tTG IgA Reagents
INOVA DIAGNOSTICS, INC. · Model 701100 · UDI-DI 08426950601890
MVM
Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
19
Facilities
Description
1. 1 QUANTA Flash h-tTG IgA reagent cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipet
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-03 | Bio-Rad Labs | An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between th |
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