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QUANTA Flash® M2 (MIT3) Reagents
INOVA DIAGNOSTICS, INC. · Model 701303 · UDI-DI 08426950730101
DBM
Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
17
Facilities
Description
1. 1 QUANTA Flash M2 (MIT3) Reagent Cartridge 2. 1 Resuspension buffer 3. 1 Transfer pipette
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-07-29 | Bio-Rad Laboratories | The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit. |
| 2004-04-12 | Diasorin Inc. | The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut o |
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