AU5800 Clinical Chemistry Analyzer The Beckman Coulter recall: Software Issue
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in…
Why was AU5800 Clinical Chemistry Analyzer The Beckman Coulter recalled?
Beckman Coulter, Inc. initiated this recall because there is a software error that has the potential to cause the reporting of erroneous patient results because of misidentification by the AU5800 system.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Instrument Serial Numbers with Software Versions 4.11 and Prior Model Numbers AU5811-01, AU5821-01, AU5831-01, AU5841-01, AU5811-02, AU5821-02, AU5831-02, AU5841-02, AU5811-03, AU5821-03, AU5831-03, AU5841-03, AU5811-04, AU5821-04, AU5831-04, AU5841-04, AU5811-06, AU5821-06, AU5831-06, AU5841-06 Part Numbers A94906, A94911, A94916, A91921 A94907, A94912, A94917, A94922 A94908, A94913, A94918, A94923 A94909, A94914, A91949, A94924 A94910, A94915, A94920, A94925 Model Numbers and Part Numbers listed above respecitively.
- Product
- AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 490
- Distribution
- Worldwide Distribution - USA, including Canada and Puerto Rico and the states of NJ, TX, CA, UT, KS, MA, NY, MI, GA, VA, IN, WI, IL, OH, NV, NC and PA. and the countries of Australia, Belgium, Czech Republic, Japan, Germany, Brazil, China, Italy, Ireland, Israel, India, Hong Kong, Malaysia, Netherlands, Spain, Switzerland, France, Taiwan, Turkey, United Kingdom and Vietnam.
- Recall date
- May 1, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)