Recall Z-1025-2015 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Beckman Coulter Inc.
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
| Date | Jan 28, 2015 (initiated Dec 15, 2014) |
| Status | Terminated |
| Reason | N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen overdose, interferes with the assays for these analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. NAC interference may lead to falsely low results. |
| Root cause | Under Investigation by firm |
| Action | A customer notification letter was sent to their customers on 12/15/14 to inform them that Beckman Coulter has recently confirmed that N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been determined to interfere with assays for the following analytes: Cholesterol OSR6X16, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers wit |
| Quantity | 59,965 units total (21,782 units in US) |
| Distribution | Nationwide in US and Puerto Rico. World Wide: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyrus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925603 | OLYMPUS CHOLESTEROL REAGENT Olympus Corp., Feb 8, 1993 |