Z-0778-04

NOW RSV Test Item Number 430-430, Kit Number 430-00R

Name: Z-0778-04 NOW RSV Test Item Number 430-430, Kit Number 430-00R
Creator: Binax, Inc.
Published: 2004-02-18
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2004-02-18 / Terminated / root cause: packaging

FDA source

Binax, Inc. began a recall of NOW RSV Test Item Number 430-430, Kit Number 430-00R on 2004-02-18. The reason FDA records is "Pouch integrity compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0778-04
Status: Terminated
Initiated: 2004-02-18
Posted: 2004-07-20
Terminated: 2004-08-09
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: NOW RSV Test Item Number 430-430, Kit Number 430-00R
Product code: GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Reason for recall: Pouch integrity compromised
Root cause tag: packaging
FDA root cause: Other
Action: Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.
Quantity in commerce: 667 kits
Distribution: KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
Product codes and lots: Lot # 015168 and 015172

Product code GQG

K032166Class IBinax Now Rsv Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065Binax, Inc. / cleared 2003-10-21

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)