Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
FDA Recall Z-1833-2017 · Posted 2017-04-17
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeJMG
Date Initiated2017-03-10
Date Terminated2017-06-27
Product Quantity889 kits total (6 kits in US)
Reason for Recall
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Firm Action
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.
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.