BinaxNOW A&B Kit 10 Test Kit (Japan) Part No. 416-110J contains NP Swabs with '8995' labeled on the swab wrapper
FDA device recall Z-0826-2007 · posted 2007-05-23 · Terminated
Recall details
- Recalling firm
- Binax, Inc. dba IMPD
- Reason for recall
- Tip of the foam swab could detach from the shaft causing injury to the patient.
- Action taken
- 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
- Status
- Terminated
- Product code
- GNX
- Quantity affected
- 3814 kits
- Distribution
- Nationwide and Japan.
- Date initiated
- 2007-03-28
- Date posted
- 2007-05-23
- Date terminated
- 2008-09-08
- Location
- Scarborough, ME
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