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Terminated

BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 80027

FDA Recall Z-0212-2009 · Posted 2008-11-03

Recalling FirmInverness Medical BioStar Inc.
Recall StatusTerminated
Product CodeGNX
Date Initiated2008-07-02
Date Terminated2008-11-04
Product Quantity509 kits

Reason for Recall

Diagnostic kits for flu were distributed with incorrect components.

Firm Action

Consignees were notified by a Important Customer Notification letter on 7/2/2008 and told to re-examine patient records that indicated a negative result and to destroy any remaining recalled product. The accompanying record should be filled out and faxed to Technical Service. If consignees further distributed any kits, they were to forward the notification to these accounts to assure that patient results were reviewed, and destruction of remaining kits could be verified. For assistance, customers can call 800-637-3717.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Nationwide Distribution --- including state of IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023556FLU OIA A/B TEST KITThermo Biostar, Inc. · 2003-03-27

Official Source

View FDA Recall →

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

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