Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Reported: October 17, 2012 Initiated: July 24, 2012 #Z-0047-2013
Product Description
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Reason for Recall
Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 5,266 units total (3,214 units in US)
- Distribution
- 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.
- Location
- Brea, CA
Frequently Asked Questions
What product was recalled? ▼
Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems. Recalled by Beckman Coulter Inc.. Units affected: 5,266 units total (3,214 units in US).
Why was this product recalled? ▼
Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 17, 2012. Severity: Moderate. Recall number: Z-0047-2013.
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