FDA-Device2017-04-26Class II
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Beckman Coulter Inc.
Hazard
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Sold states
Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Zimbabwe.
Affected count
889 kits total (6 kits in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1833-2017Don't want to check this manually?
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