FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.

FDA device recall Z-0002-2008 · posted 2007-10-16 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc

Reason for recall

Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.

Action taken

A Product Corrective Action (PCA) letter was mailed on Feb 22, 2007, to all FP1000 customers to inform them of an issue associated with the FP1000 Cell Preparation System. Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented. Under these conditions the FP1000 will under-dispense specimen volume leading to lower than expected absolute counts. Specimen tubes that are recapped or underfilled must therefore be vented prior to running on the FP1000. If the initial state of the specimen tube is unknown, then it must be vented to ensure accurate results prior to running on the FP1000. Additional instructions are provided. A Fax Back Response Form was also provided.

Root cause

Labeling design

Status

Terminated

Product code

LXG

Quantity affected

9 in the U.S.; 1 in Canada

Distribution

Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.

Date initiated

2007-02-22

Date posted

2007-10-16

Date terminated

2012-04-26

Location

Brea, CA