PerkinElmer Life Sciences Inc Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
Brand
PerkinElmer Life Sciences Inc
Lot Codes / Batch Numbers
Lot #164738
Products Sold
Lot #164738
PerkinElmer Life Sciences Inc is recalling Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label due to The kits are producing lower values than expected, which may result in an increase of false positive test results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The kits are producing lower values than expected, which may result in an increase of false positive test results.
Recommended Action
Per FDA guidance
The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.
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
AL, AZ, CO, CT, FL, IN, LA, MO, NJ, OH
Page updated: Jan 10, 2026