FDAClass IIApril 26, 2017

Access Ferritin Calibrators recall

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

Why was Access Ferritin Calibrators recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot No. 671094

Product
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Recalling firm
Beckman Coulter Inc.
Quantity
889 kits total (6 kits in US)
Distribution
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.
Recall date
April 26, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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