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Terminated

NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use Product Code: 852-000

FDA Recall Z-0222-2007 · Posted 2006-11-29

Recalling FirmInverness Medical Professional Diagnostics
Recall StatusTerminated
Product CodeMJH
Date Initiated2006-09-29
Date Terminated2007-03-13
Product Quantity531 kits

Reason for Recall

Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches

Firm Action

Binax Inc. DBA Inverness Medical notified consignees by letter on 09/29/06 advising users to return unused product and distributors to recall to the user level.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, EU, South Korea, Singapore

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982238BINAX NOW LEGIONELLA URINARY ANTIGEN TEST MODEL 852-020 AND BINAX NOW LEG IONELLA URINARY ANTIGEN CONTROL KIT MODEL 8522Binax, Inc. · 1998-08-21

Official Source

View FDA Recall →

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

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