Unicel DxH 800 Coulter Cellular Analysis System. Beckman Coulter, Inc. Brea, CA. Quantitative, automated hematology anal
FDA device recall Z-1658-2010 · posted 2010-05-26 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 56 units
- Distribution
- Distributed Nationwide and Canada.
- Date initiated
- 2010-02-04
- Date posted
- 2010-05-26
- Date terminated
- 2014-09-02
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K081930) | Beckman Coulter, Inc. | 2008-12-19 |