Rappel de COULTER GENS System

Recall

44916

Class 2

Z-0315-2008

2007-04-18

2007-12-22

Terminated

United States

2012-04-16

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64532

Patient mis-identification can occur: 1)- when a positive identifier (sample id or cassette/position) is manually edited to a positive identifier that is already in the to do list. the workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2)- when manually entering a patient id, if a blank space is entered between th.

Product Corrective Action (PCA) letters were mailed on April 18,2007, to all GENS, LH500, LH750 and LH780 accounts. They are informed that a potential misidentification can occur in 2 scenarios. 1. When a positive identifier (Sample ID or CassetteIPosition) is manually edited to a positive identifier that is already in the ToDo list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier. 2. When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.----Short term fix----- The letter explains the issues and provides the customer work around. (Letters were sent by US mail). A customer response form was provided. The root cause of the problem is still under investigation, software upgrades, when approved will be made to devices.