Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
- Company
- Perkinelmer Las Inc
- Recall Initiated
- September 8, 2004
- Posted
- September 30, 2004
- Terminated
- October 29, 2008
- Recall Number
- Z-1499-04
- Quantity
- 49 kits
- Firm Location
- Norton, OH
Reason for Recall
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.
Distribution
The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.
Lot / Code Info
Lot #244468
Root Cause
Other
Action Taken
The firm contacted their consignees by letter sent 9/8/04.