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Pointe G6PD Controls
HORIBA INSTRUMENTS INCORPORATED · Model G7583-CTL · UDI-DI 00811727015679
JBF
Prescription
1
510(k) clearances
7
Adverse events
1
Recalls
6
Facilities
Description
Pointe G6PD Controls, 2x0.5ml L1, 2x0.5ml L2, Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood. For in vitro diagnostic use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-05-19 | Pointe Scientific, Inc. | A reduction in the reconstituted stability has been identified. Clinicians may notice a drop in recovery of the control after reconstitution, which could result in an out of specif |
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