Company:Beckman Coulter Inc
Date of Enforcement Report 1/2/2008
Class:ll
PRODUCT
a) COULTER LH750 Analyzer, Part Number: 6605632, Hematology analyzer,
Recall # Z-0312-2008;
b) COULTER LH780 Analyzer, Part Number: 723585, Hematology analyzer,
Recall # Z-0313-2008;
c) COULTER LH 500 Series System, Part Number: 178833, Hematology analyzer,
Recall # Z-0314-2008;
d) COULTER GEN*S System, Part Number: 6605381, Hematology analyzer,
Recall # Z-0315-2008
REASON
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 the characters in the Patient ID field, the system will only accept the characters before the space.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA, by letters on April 18, 2007.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3,973 units in the US; 321 units in Canada
DISTRIBUTION
Nationwide and Canada
