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QUANTA Flash® B2GP1 IgM Reagents
INOVA DIAGNOSTICS, INC. · Model 701250 · UDI-DI 08426951289271
MSV
Prescription
1
510(k) clearances
0
Adverse events
1
Recalls
18
Facilities
Description
1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge 2. 1 QUANTA Flash B2GP1 IgM Calibrator 1 3. 1 QUANTA Flash B2GP1 IgM Calibrator 2
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-10-26 | Diasorin Inc. | Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, |
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