Recall Z-1658-2010 ยท GKZ Counter, Differential Cell
Beckman Coulter Inc.
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.
| Date | May 26, 2010 (initiated Feb 4, 2010) |
| Status | Terminated |
| Reason | 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 | 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 | 56 units |
| Distribution | Distributed Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081930 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM Beckman Coulter, Inc., Dec 19, 2008 |