—#50283

Product

Coulter LH700 Series Hematology Analyzers, Part Number 6605632 with 2B Software (2B3, 2B4 and 2B5)

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, with 2B Software (2B3, 2B4 and 2B5)

Why it was recalled

There is a potential for erroneous yet credible results for Body Fluids on the LH700 series hematology analyzers when a cassette label fails to read and the subsequent sample is cycled in Body Fluid mode.

Root cause (FDA determination)

Other

Action the firm took

A Product Corrective Action (PCA) letter was mailed on Sep 12, 2006 to all LH 750 accounts to inform them that there is an issue with COULTER LH 700 Series analyzer software that could affect the Body Fluid analysis and that this this anomaly is present only in Software revisions of 2B. The letter instructs the customer on how to determine their software version. Immediate user preventive action was provided in the letter which is to reset the analyzer when a cassette label read error occurs. The letter advises that this information be shared with laboratory staff and be retained as part of their Quality System documentation. A customer response form was also included.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2006-09-12
Posted by FDA: 2007-03-06
Terminated: 2012-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50283. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.