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Recall Observatory FDA recall evidence

Device product

Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C

Z-1833-2017

March 10, 2017

Class II

Product summary

Firm
Beckman Coulter Inc.
Event
Event 76838
Status
Terminated
Classification
Class II
Quantity
889 kits total (6 kits in US)
Official record key
device-enforcement:Z-1833-2017

Official wording

Reason: Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

Code information: Lot No. 671094

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.