Trima Accel Automated Blood Collection System, catalog number 917000000, Caridian BCT, Lakewood, CO 80215 USA. Product Usage: Automated Blood Collection System for use in humans.
FDA Recall Z-1541-2012 · Posted 2012-05-11
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Recalling FirmCaridianBCT, Inc.
Recall StatusTerminated
Product CodeKZE
Date Initiated2010-06-01
Date Terminated2012-07-25
Product Quantity2278 units
Reason for Recall
Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in compliance with the most current FDA guidance for post donation platelet count targets.
Firm Action
CaridianBCT sent a Letter notification dated March 2011 to consignees The letter identified the upcoming software updates to version 6.0.1 as well as operations manual changes. For questions contact your CaridianBCT Representative, the CaridianBCT Support Center at +1-877-339-4228 or 1-303-231-4357 or your local CaridianBCT Customer Service office.
Root Cause
Software design
Distribution Pattern
USA Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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