NOW RSV Test recallZ-0778-04 · Binax, Inc. · initiated Feb 18, 2004
Terminated All recalls posted in July 2004
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. 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
Pouch integrity compromised
FDA root cause category: Other
What the company is doing
Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.
Recall details
- Recall number
- Z-0778-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 18, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Binax, Inc.
- Quantity
- 667 kits
- Product code
- GQG
- FDA submissions
- K032166
- Distribution
- KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India
Product description
NOW RSV Test Item Number 430-430, Kit Number 430-00R
Code information (models, lots, serial numbers)
Lot # 015168 and 015172
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.
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