BinaxNOW RSV 10 Test Kit recallZ-0824-2007 · Binax, Inc. dba IMPD · initiated Mar 28, 2007
Terminated All recalls posted in May 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Binax, Inc. dba IMPD or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Tip of the foam swab could detach from the shaft causing injury to the patient.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0824-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 28, 2007
- Posted by the FDA
- May 23, 2007
- Recalling firm
- Binax, Inc. dba IMPD
- Quantity
- 2851 kits
- Product code
- GQG
- FDA submissions
- K032166
- Distribution
- Nationwide and Japan.
Product description
BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper
Code information (models, lots, serial numbers)
Kit Lot Numbers: 023437, 024056, 024057, 024436, 024516, 024518, 024694, 024695, 024882, 025090, 025089 NP Swabs Lot Number: 8995
Other devices under the same FDA submission
1 device cleared under K032166 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BinaxNOW RSV 430-122Alere Scarborough, Inc. · Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page