—#64528

Product

COULTER LH750 Analyzer, Part Number 6605632, Beckman Coulter, Brea, CA. (Beckman Coulter, Brea, CA. (Hematology analyzer)

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K011342
Affected lot / code info: Part Number 6605632. All software versions

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: World wide: USA and Canada

Timeline

Recall initiated: 2007-04-18
Posted by FDA: 2007-12-22
Terminated: 2012-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #64528. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.