FDAFDA · Food and drugs·Recall number Z-0047-2013
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Published October 17, 2012 · Recall initiated: July 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- 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.
- Lot
- Lot# 122651, 123635, 219962
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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