VITROS — Class II medical device recall Z-1805-2014

Terminated recall by Ortho-Clinical Diagnostics, reported 2014-06-25, distributed nationwide. Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergo

Recall number	`Z-1805-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Ortho-Clinical Diagnostics, Rochester, NY, United States
Recall initiated	2014-05-12
Classified	2014-06-16
Reported by FDA	2014-06-25
Terminated	2017-03-23
Distributed	Nationwide (US)
Countries outside the US	AU, BR, CA, CL, CN, CO, DE, ES, FR, GB, IN, IT, JP, MX, PA, SG, VE
Lot numbers	`91131`
Model numbers	`6801873`
Expiration dates	`2015-03-07`, `2016-02-28`

Product

VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason for recall

Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.

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-1805-2014. 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.