Z-1499-04

Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000

Name: Z-1499-04 Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000
Creator: PerkinElmer LAS Inc
Published: 2004-09-08
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2004-09-08 / Terminated / root cause: manufacturing process

FDA source

PerkinElmer LAS Inc began a recall of Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000 on 2004-09-08. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1499-04
Status: Terminated
Initiated: 2004-09-08
Posted: 2004-09-30
Terminated: 2008-10-29
Recalling firm: Revvity Health Sciences, Inc.
Product: Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000.
Product code: JIA Enzymatic Methods, Galactose
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.
Root cause tag: manufacturing process
FDA root cause: Other
Action: The firm contacted their consignees by letter sent 9/8/04.
Quantity in commerce: 49 kits
Distribution: The kits were distributed to 5 consignees, located in Indianapolis, IN; Jefferson City, MO; Austin, TX; Madison, WI; and Minneapolis, MN.
Product codes and lots: Lot #244468

Product code JIA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)