Binax, Inc. dba IMPD BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labeled on the swab wrapper
Brand
Binax, Inc. dba IMPD
Lot Codes / Batch Numbers
Kit lot Numbers: 023357, 023566, 024629, 024631
Products Sold
Kit lot Numbers: 023357, 023566, 024629, 024631,
Binax, Inc. dba IMPD is recalling BinaxNOW Nasopharyngeal (NP) Accessory Pak, Part Number 400-065, contain NP Swabs with '8995' labele due to Tip of the foam swab could detach from the shaft causing injury to the patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Tip of the foam swab could detach from the shaft causing injury to the patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026