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

FDA device recall Z-1833-2017 · posted 2017-04-17 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

JMG

Quantity affected

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, I

Date initiated

2017-03-10

Date posted

2017-04-17

Date terminated

2017-06-27

Location

Brea, CA

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