Z-1139-03

Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog...

Name: Z-1139-03 Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog...
Creator: PerkinElmer Life Sciences Inc
Published: 2003-06-27
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2003-06-27 / Terminated

FDA source

PerkinElmer Life Sciences Inc began a recall of Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100 on 2003-06-27. The reason FDA records is "The kits are producing lower values than expected, which may result in an increase of false positive test results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1139-03
Status: Terminated
Initiated: 2003-06-27
Posted: 2003-08-20
Terminated: 2008-10-24
Recalling firm: Revvity Health Sciences, Inc.
Product: Neonatal GALT Test Kit, 4800 assays per kit, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-4100.
Product code: JLJ Uridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-Phosphate
Reason for recall: The kits are producing lower values than expected, which may result in an increase of false positive test results.
FDA root cause: Other
Action: The firm contacted their customers by telephone and fax on 6/27/03 and 7/1/03.
Quantity in commerce: 85 kits
Distribution: The kits were shipped to ten (10) State Health Laboratories in AL, CT, AZ, CO, FL, IN, LA, MO, NJ, OH.
Product codes and lots: Lot #164738

Product code JLJ

K950803Class IIsolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 SampleIsolab, Inc. / cleared 1995-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)