Data Foundry

Medical device recalls 2017

Access Ferritin Calibrators — Class II medical device recall Z-1833-2017

Terminated recall by Beckman Coulter Inc., reported 2017-04-26. Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with a

Recall numberZ-1833-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBeckman Coulter Inc., Brea, CA, United States
Recall initiated2017-03-10
Classified2017-04-17
Reported by FDA2017-04-26
Terminated2017-06-27
Countries outside the USBD, BE, CH, CZ, DE, DK, DZ, EG, ES, FR, GB, GH, GR, HR, HU, IE, IT, LB, LT, MA, NL, NP, OM, PK, PL, PT, RO, RU, SA, SE, SK, TR, ZA
Lot numbers671094
Model numbers33025, B50136C

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1833-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.