FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
- Recall number
- Z-1833-2017
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
- Status
- Terminated
- Initiated
- 2017-03-10
- Posted
- 2017-04-17
- Terminated
- 2017-06-27
- Reason
- Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
- Root cause
- Other
- 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.
- 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.
- Lot, serial or model codes
- Lot No. 671094
- 510(k) numbers
- ["K052082","K926221"]
- PMA numbers
- not on file
- Product code
- JMG
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28