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Terminated

BinaxNOW RSV 10 Test Kit Part Number : 430-100, contains NP Swabs with '8995' labeled on the swab wrapper

FDA Recall Z-0824-2007 · Posted 2007-05-23

Recalling FirmBinax, Inc. dba IMPD
Recall StatusTerminated
Product CodeGQG
Date Initiated2007-03-28
Date Terminated2008-09-08
Product Quantity2851 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K032166BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065Binax, Inc. · 2003-10-21

Official Source

View FDA Recall →

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

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