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Terminated

BD FACS Sample Prep Assistant II, Part Number: 337170; Product is manufactured and distributed by BD Biosciences, San Jose, CA 95131

FDA Recall Z-0526-2008 · Posted 2008-04-10

Recalling FirmBD Biosciences
Recall StatusTerminated
Product CodeGKI
Date Initiated2007-10-02
Date Terminated2010-12-13

Reason for Recall

Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.

Firm Action

On 10/1/07, all consignees were notified via Important Product Information letter and also an on-site visit by the firm's sales representative. The letter informed users of the affected product and provided instructions on the recall. For additional concerns or questions contact BD Customer Support Center at 1-877-232-8995.

Root Cause

Software change control

Distribution Pattern

Worldwide Distribution --- USA including states of: NJ, IL, TX, PA, NY, MN, and AZ, and countries of Australia, Belgium, Hong Kong, Trinidad and Tobago. Australia, Belgium, Hong Kong, Trinidad and Tobago.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050191MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWAREBecton, Dickinson & CO · 2005-02-22

Official Source

View FDA Recall →

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

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