—#90221

Product

Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology analyzer and for in vitro diagnostic use in screening patient populations found in clinical laboratories.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K081930
Affected lot / code info: Part number: 629029; All Serial Numbers.

Why it was recalled

Issue 1: The system will substitute or omit the characters # @ 1 \ ] ' ( I ) - when the instrument is configured in a language other than English, Chinese or Japanese. Example: Using the character @, a substitution in the string '123@456' would result in '123#456' and an omission would result in '123456'. Issue2: The characters 7 " and * (question mark, quotation mark, and asterisk) used as part

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 #90221. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.