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U.S. Department of Health and Human Services

Class 2 Device Recall Uric AcidOSR6x98

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  Class 2 Device Recall Uric AcidOSR6x98 see related information
Date Initiated by Firm April 13, 2016
Create Date June 08, 2016
Recall Status1 Terminated 3 on June 30, 2016
Recall Number Z-1932-2016
Recall Event ID 73921
510(K)Number K062862  
Product Classification Acid, uric, uricase (colorimetric) - Product Code KNK
Product Uric Acid, Catalog No. OSR6x98

Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
Code Information All lots
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Mark Price
714-961-4933
Manufacturer Reason
for Recall		 Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.
FDA Determined
Cause 2		 Device Design
Action Beckman Coulter sent an Urgent Medical Device Recall letter dated April 13, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions regarding the customer notification letter are instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support; (800) 223-0130 in the US and Canada. Outside of the US and Canada, customers are instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 59,401 units total (10,868 units in US)
Distribution Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNK and Original Applicant = OLYMPUS AMERICA, INC.
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