Z-0824-2007

BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper

Name: Z-0824-2007 BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper
Creator: Binax, Inc. dba IMPD
Published: 2007-03-28
License: https://open.fda.gov/license/

Abbott Diagnostics Scarborough, Inc. / initiated 2007-03-28 / Terminated

FDA source

Binax, Inc. dba IMPD began a recall of BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper on 2007-03-28. The reason FDA records is "Tip of the foam swab could detach from the shaft causing injury to the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0824-2007
Status: Terminated
Initiated: 2007-03-28
Posted: 2007-05-23
Terminated: 2008-09-08
Recalling firm: Abbott Diagnostics Scarborough, Inc.
Product: BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper
Product code: GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Reason for recall: Tip of the foam swab could detach from the shaft causing injury to the patient.
FDA root cause: Other
Action: Inverness Medical issued recall notification by letter on 3/28/07. Customers are instructed to discard the NP swabs provided in the kits. The firm will replace the NP swabs. In the meantime customers are to use the tests with nasal wash/aspirate samples (influenza) or nasal wash samples (RSV). Response letters are to be signed by customers and returned to Inverness Medical.
Quantity in commerce: 2851 kits
Distribution: Nationwide and Japan.
Product codes and lots: Kit Lot Numbers: 023437, 024056, 024057, 024436, 024516, 024518, 024694, 024695, 024882, 025090, 025089 NP Swabs Lot Number: 8995

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)