Recall Z-1024-2015
Beckman Coulter Inc. · initiated December 15, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Beckman Coulter, Uric Acid Assay, Catalog No. OSR6X98
Codes / lots: All Lots
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 with questions are instructed to call (800) 223-0130 in the US and Canada. Customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Details
- Recall number
- Z-1024-2015
- Initiated
- December 15, 2014
- Posted by FDA
- January 28, 2015
- Terminated
- February 19, 2016
- Product code
- KNK – Acid, Uric, Uricase (Colorimetric)
- Quantity
- 32,159 units total (10,462 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, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong…
- Recalling firm
- Beckman Coulter Inc., Brea, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1023-2015 Class II | Beckman Coulter, Lipase Assay, Catalog No. OSR6X30N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen… | 12/15/2014Terminated |
| Z-1025-2015 Class II | Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen… | 12/15/2014Terminated |
| Z-1026-2015 Class II | Beckman Coulter, Lactate Assay, Catalog No. OSR6X93N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations for the treatment of acetaminophen… | 12/15/2014Terminated |