Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
Reported: February 4, 2015 Initiated: December 15, 2014 #Z-1025-2015
Product Description
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16
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.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 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, 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, Viet Nam, Zambia, and Zimbabwe
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Beckman Coulter, Cholesterol Assay, Catalog No. OSR6X16. Recalled by Beckman Coulter Inc.. Units affected: 59,965 units total (21,782 units in US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 4, 2015. Severity: Moderate. Recall number: Z-1025-2015.
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