—#90220

Product

Coulter LH 500 Series System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and leukocyte differential cell counter for in vitro diagnostic use in clinical laboratories.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K032000
Affected lot / code info: Product LH500 100V Part number 178832; Product LH500 120V Part number 178833; Product LH500 240V Part Number 178834; All Serial Numbers.

Why it was recalled

Issue 1: The system will substitute or omit the characters # @ [\] ' {I) when the system is configured in a language other than English or Chinese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456' Issue 2: The system will omit the character ~ regardless of language. Impact: There is a potential for Specimen

Root cause (FDA determination)

Software design

Action the firm took

Beckman Coulter, Inc. issued "Urgent: Product Corrective Action" notifications dated February 12, 2010. Consignees were informed of the affected product and instructed on proper actions. The firm also asked that the enclosed response forms be returned. For further information, contact your local Beckman Coulter Representative or call 1-800-526-7694.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: Distributed Nationwide and Canada.

Timeline

Recall initiated: 2010-02-04
Posted by FDA: 2010-05-26
Terminated: 2014-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.