BD FACS Sample Prep Assistant III; (BD SPA III), Manufactured by BD Biosciences, San Jose, CA. The intended use for the

FDA device recall Z-0316-2011 · posted 2010-11-03 · Terminated

Recall details

Recalling firm

BD Biosciences, Systems & Reagents

Reason for recall

Due to inaccurate sample dispense, use of product may result in getting incorrect results on samples prepared using the device. Having a piece of the lid partially or fully clogging the Probe during piercing a hole in the lid of tube may cause inaccurate sample dispense, resulting in incorrect test results. The piece of the lid clogging the Probe can be in the processed sample tube. It has the

Action taken

BD Biosciences sent an "Important Product Information" letter dated February 2010 and an "URGENT: Follow-Up to Letter Dated February 2010" letter dated July 2010 to customers identifying the affected device and actions to be taken: Customers were instructed to stop use of the SPA probes and to contact BD for replacement of the affected probes and assistance in the event of probe clogging. BD has arranged replacement of affected probes. BD's followup communication detailed the potenial hazards and reiterated remedial actions in the event of error messages from FACS flow cytometers. Customers with questions about the performance of theirr SPA instrument or the content of the letters may contact BD Customer Support at 1.877.232.8995, prompt 2.

Root cause

Device Design

Status

Terminated

Product code

GKZ

Quantity affected

349 units

Distribution

Worldwide distribution: USA including OH, NC, AL,TX, FL, CA, NY, and MN and the country of Belgium.

Date initiated

2010-02-19

Date posted

2010-11-03

Date terminated

2011-05-18

Location

San Jose, CA