Z-1140-03

Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

Name: Z-1140-03 Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
Creator: Perkinelmer Life Sciences, Inc.
Published: 2003-07-21
License: https://open.fda.gov/license/

Revvity Health Sciences, Inc. / initiated 2003-07-21 / Terminated / root cause: labeling and UDI

FDA source

Perkinelmer Life Sciences, Inc. began a recall of Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103 on 2003-07-21. The reason FDA records is "Product's outer carton label was labeled with an extended 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-1140-03
Status: Terminated
Initiated: 2003-07-21
Posted: 2003-08-20
Terminated: 2003-11-19
Recalling firm: Revvity Health Sciences, Inc.
Product: Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103
Product code: DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Reason for recall: Product's outer carton label was labeled with an extended expiration date
Root cause tag: labeling and UDI
FDA root cause: Other
Action: PerkinElmer notified customers by telephone on 7/21/2003 of the expiration date error on the outer carton label . A recall letter issued on 7/25/03 and a verification form was requested to be completed and returned.
Quantity in commerce: 69 kits
Distribution: CA, PA, IN, MO Foreign: Switzerland
Product codes and lots: Lot Number: 181578

Product code DHN

K843347Class IIRianen Anit-Double Stranded DeoxyribonE.I. Dupont DE Nemours & Co., Inc. / cleared 1984-10-05

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)