Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper

FDA Recall Z-0826-2007 · Posted 2007-05-23

Recalling FirmBinax, Inc. dba IMPD
Recall StatusTerminated
Product CodeGNX
Date Initiated2007-03-28
Date Terminated2008-09-08
Product Quantity3814 kits

Reason for Recall

Tip of the foam swab could detach from the shaft causing injury to the patient.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide and Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑