Beckman Coulter AU5800 Clinical Chemistry Analyzer. An automated chemistry analyzer that measures analytes such as Gluco
FDA device recall Z-0913-2013 · posted 2013-03-06 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Due to a software data storage limitation which only occurs under certain conditions, measurements of the Reagent Blank (RB) or Calibration (CAL) sample results are not saved and the software reverts to a previously stored, acceptable RB/CAL result.
- Action taken
- Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 28, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Call Center Hotline at (800) 854-3633 for questions regarding the notice.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 28 in U.S.; 4 Canada; 318 to other foreign countries.
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Brazil, China, Czech Republic, France, Germany, Hungary, India, Ireland, Israel, Italy, Korea Republic, Mala
- Date initiated
- 2012-11-28
- Date posted
- 2013-03-06
- Date terminated
- 2014-02-24
- 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 |