Recall Z-1930-2016
Beckman Coulter Inc. · initiated April 13, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
Codes / lots: All lots
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: Device Design
Action taken
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.
Details
- Recall number
- Z-1930-2016
- Initiated
- April 13, 2016
- Terminated
- June 30, 2016
- Product code
- CDT – Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- Quantity
- 32,926 units total (6,041 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…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1931-2016 Class II | Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System…Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the… | 04/13/2016Terminated |
| Z-1932-2016 Class II | Uric Acid, Catalog No. OSR6x98 Product Usage:Uric acid OSR6x98 is intended as a System…Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the… | 04/13/2016Terminated |
| Z-1933-2016 Class II | Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a…Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the… | 04/13/2016Terminated |
| Z-1934-2016 Class II | Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an…Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the… | 04/13/2016Terminated |