PerkinElmer LAS Inc Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
Brand
PerkinElmer LAS Inc
Lot Codes / Batch Numbers
Lot #244468
Products Sold
Lot #244468
PerkinElmer LAS Inc is recalling Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000. due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The firm contacted their consignees by letter sent 9/8/04.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MN, MO, TX, WI
Page updated: Jan 10, 2026