Home › DRG International Inc › Galactose (with Membrane Plate) ELISA
Galactose (with Membrane Plate) ELISA
DRG International Inc · Model EIA-1486 · UDI-DI 00840239014863
JIA
Prescription
9
510(k) clearances
0
Adverse events
6
Recalls
2
Facilities
Description
The DRG Galactose kit is designed for the quantitative determination of galactose in neonatal blood spots. It is for in-vitro diagnostic use as an aid in screening newborns for the elevated galactose levels as seen in galactosemia.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2004-09-08 | PerkinElmer LAS Inc | There is an increase in the number of normal specimen results below the lowest calibrator and based on a report that the normal controls were running low, sometimes out of the spec |
| 2004-01-09 | Perkin Elmer Life and Analytical Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2004-01-09 | Perkin Elmer Life and Analytical Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
| 2003-05-30 | PerkinElmer Life Sciences Inc | The device is not stable throughout its labeled expiration date. |
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