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U.S. Department of Health and Human Services

Enforcement Report - Week of October 17, 2012

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Event Detail

Event ID 63169
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-24
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems Lot# 122651, 123635, 219962 Class II Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. 5,266 units total (3,214 units in US) Z-0047-2013
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems. Lot# 112788, 115741, 118917 Class II Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. 4,635 units total (3,214 units in US) Z-0046-2013
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