Recall Z-1499-04 ยท JIA Enzymatic Methods, Galactose
PerkinElmer LAS Inc
Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
| Date | Sep 30, 2004 (initiated Sep 8, 2004) |
| Status | Terminated |
| Reason | 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 specified range. |
| Root cause | Other |
| Action | The firm contacted their consignees by letter sent 9/8/04. |
| Quantity | 49 kits |
| Distribution | The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.