—#34717

Product

COULTER LH 500 Hematology Analyzer part numbers: 178832, 178833, and 178834 software versions 1A and 1A2. The LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter For In Vitro Diagnostic Use in clinical laboratories. The LH %500 Analyzer also provides a semi-automated reticulocyte analysis.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K032000
Affected lot / code info: Part Numbers: 178832, 178833, and 178834 software versions 1A and 1A2.

Why it was recalled

Beckman Coulter has confirmed an issue associated with the predilute mode of the COULTER LH 500 Hematology Analyzer. The workstation may display, transmit, and / or print an erroneous result or an incorrect dilution factor with a predilute sample result.

Root cause (FDA determination)

Other

Action the firm took

Customers were notified via U.S. mail by a Product Corrective Action Letter (PCA) dated August 12, 2004. The letter includes a description of what conditions need to be met for the error to occur and the proper steps to prevent the issue from occurring.

Recalling firm

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

Distribution

Distribution pattern: Nationwide & Canada

Timeline

Recall initiated: 2004-08-12
Posted by FDA: 2004-09-02
Terminated: 2012-04-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #34717. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.