Beckman Coulter Inc Hematology Analyzer Cl II

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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