Z-1833-2017Class II

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

Name: Z-1833-2017 Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Creator: Beckman Coulter Inc.
Published: 2017-03-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-03-10 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C on 2017-03-10. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1833-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-10
Posted: 2017-04-17
Terminated: 2017-06-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Product code: JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin
Reason for recall: Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot No. 671094

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1833-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1833-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-17

Product code JMG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)