Z-0515-04

Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000

Name: Z-0515-04 Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
Creator: Perkin Elmer Life and Analytical Sciences Inc
Published: 2004-01-09
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2004-01-09 / Terminated / root cause: labeling and UDI

FDA source

Perkin Elmer Life and Analytical Sciences Inc began a recall of Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000 on 2004-01-09. The reason FDA records is "The device is not stable throughout its labeled expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0515-04
Status: Terminated
Initiated: 2004-01-09
Posted: 2004-07-20
Terminated: 2008-10-29
Recalling firm: Revvity Health Sciences, Inc.
Product: Neonatal Total Galactose Test Kit, contents for 4800 assays, Item #NG-4000
Product code: JIA Enzymatic Methods, Galactose
Reason for recall: The device is not stable throughout its labeled expiration date.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm contacted their customers by letter on 1/9/2004.
Quantity in commerce: 178 kits
Distribution: The kits were shipped to domestic end-users located in NJ, PA, TX, IN, MI, MO, IL, CO, CT, AR, FL, LA, OH, NM, WA.
Product codes and lots: Lots #178052, Exp 2/7/04; #182567, Exp 1/7/04; #195339, Exp 2/18/04; #207487, Exp 4/29/04.

Product code JIA

K950481Class INeonatal Chemistry System, Galactose Test KitIsolab, Inc. / cleared 1996-02-01

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)