Medical Device Recall: Z-0002-2008

FDA Recalls dataset · Firm: Beckman Coulter Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2007-02-22 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2008.

Recall Res Number
Z-0002-2008
Recalling Firm / Manufacturer
Beckman Coulter Inc
FEI Number
2050012
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2007-02-22
Date Posted
2007-10-16
Date Terminated
2012-04-26
Product Code
LXG
Event Number
38369
Product Quantity
9 in the U.S.; 1 in Canada
Product Description FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Reason for Recall Pressure (from recapped tubes) or vacuum (from under-filled short-draw tubes) will cause inaccurate results if not properly vented.
Action Details 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.
Distribution Pattern Nationwide (MA, IN, IL, UT, RI, NJ), and Canada.
Code Information / Serial Numbers Part Number 624922. Software versions 1.1 & 1.2

Related Establishments / Registrations

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