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Terminated

NOW RSV Test Item Number 430-430, Kit Number 430-00R

FDA Recall Z-0778-04 · Posted 2004-07-20

Recalling FirmBinax, Inc.
Recall StatusTerminated
Product CodeGQG
Date Initiated2004-02-18
Date Terminated2004-08-09
Product Quantity667 kits

Reason for Recall

Pouch integrity compromised

Firm Action

Binax initiated the recall on 2/18/04 by telephone or email to customers. European customers were notiified by letter.

Root Cause

Other

Distribution Pattern

KS International: Australia, New Zealand, Japan,Sri-Lanka France, The Netherlands, U.A.E., Oman, S. Africa, Hong Kong, Zimbabwe, India

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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