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Terminated

BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, BD Biosciences, San Jose, CA 95131.

FDA Recall Z-0570-2008 · Posted 2008-03-04

Recalling FirmBD Biosciences
Recall StatusTerminated
Product CodeGKZ
Date Initiated2007-09-06
Date Terminated2008-04-15
Product Quantity1136 units

Reason for Recall

Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.

Firm Action

Becton Dickinson sent an Important Product Information letter by mail on 09/14/2007 informing customers of the need to follow the instructions for adjusting the lymph gate or attractors. The next software revision will alleviate this limitation.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA, Belgium, Brazil, Peru, Singapore, Canada, Jamaica, Chile, Ecuador, Hong Kong-China, Thailand, Mexico, Venezuela, Barbados, Philippines, Puerto Rico, Guatemala, Japan, Uruguay, Argentina, China, Trinidad and Tobago, Honduras, Australia, New Zealand, and India.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963963MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSISBecton Dickinson Immunocytometry Systems · 1996-12-12

Official Source

View FDA Recall →

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

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