Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures an
FDA device recall Z-1873-2013 · posted 2013-08-02 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition of the on/off valve.
- Action taken
- A recall notification letter was forwarded to all their customers on 11/1/12 who purchased the AU5800 Clinical Chemistry Analyzer. The customers were informed of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Reponse form within 10 days. Customers with questions are instructed to call (800) 854-3633 or contact their local BCI Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 338 units (11 units in the US)
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Germany, China, Austria, Brazil, Italy, Argentina, Korea, Vietnam, Hungary, Ireland, France, Spain, Turkey, Switzerland, Is
- Date initiated
- 2012-10-26
- Date posted
- 2013-08-02
- Date terminated
- 2013-10-18
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AU5800(R) CHEMISTRY ANALYZER (K112412) | Beckman Coulter, Inc. | 2011-12-23 |