Recall Z-1657-2010 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
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.
| Date | May 26, 2010 (initiated Feb 4, 2010) |
| Status | Terminated |
| Reason | 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 | Software design |
| 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. |
| Quantity | 1520 units |
| Distribution | Distributed Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032000 | COULTER LH 500 HEMATOLOGY ANALYZER Beckman Coulter, Inc., Aug 13, 2003 |