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 Recall Z-1657-2010 · Posted 2010-05-26
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Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeGKZ
Date Initiated2010-02-04
Date Terminated2014-09-02
Product Quantity1520 units
Reason for Recall
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
Firm Action
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.
Root Cause
Software design
Distribution Pattern
Distributed Nationwide and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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