—#154369

Product

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

FDA product code: JMG — Radioimmunoassay (Two-Site Solid Phase), Ferritin
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K052082, K926221
Affected lot / code info: Lot No. 671094

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

Beckman Coulter sent an Urgent Medical Device Recall letter dated March 10, 2017, to inform them that Beckman Coulter has determined through customer feedback that a portion of the Access Ferritin Calibrators kit lot listed above contains a calibration card with an incorrect S5 calibrator concentration. The S5 concentration value printed on the card and encoded in the barcode is 1.500 (ng/mL) rather than the correct concentration of 1500 (ng/mL). Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Technical Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 the US and Canada and customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

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.

Timeline

Recall initiated: 2017-03-10
Posted by FDA: 2017-04-17
Terminated: 2017-06-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154369. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.