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Terminated

BD Biosciences, BD FACS Sample Prep Assistant II (SPA II), blood sample preparer for flow cytometry analysis

FDA Recall Z-1940-2010 · Posted 2010-06-30

Recalling FirmBD Biosciences, Systems & Reagents
Recall StatusTerminated
Product CodeGKZ
Date Initiated2010-02-19
Date Terminated2011-05-18
Product Quantity349 units

Reason for Recall

Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe

Firm Action

The firm filed an MDR and implemented a field action consisting of a February 2010 notification letter and product replacement of affected probes. A CAPA for the probe design has been implemented. Effectivity is being tracked via mail and follow up phone call.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution: USA, Australia, Belgium, China (Hong Kong), Colombia, Jamaica, Korea, Mexico, Singapore and Uruguay.

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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