GSP Neonatal Total Galactose Kit
Wallac Oy · Model 3309-001U · UDI-DI 06438147328031
JIA
Prescription
1
510(k) clearances
0
Adverse events
6
Recalls
2
Facilities
Description
For the quantitative determination of total galactose concentration in dried blood. Note: Kit contains multiple packages.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.