Recall Z-1934-2016 ยท CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Beckman Coulter Inc.
Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
| Date | Apr 13, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 79,009 units total (21,215 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, Denmar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM Olympus America, Inc., Mar 23, 2007 |