Z-1193-2014Class III

VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD...

Name: Z-1193-2014 VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD...
Creator: Ortho-Clinical Diagnostics
Published: 2014-01-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-01-15 / Terminated / root cause: design

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators --... on 2014-01-15. FDA classified it as Class III and gives the reason as "Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1193-2014
Classification: Class III
Status: Terminated
Initiated: 2014-01-15
Posted: 2014-03-12
Terminated: 2017-04-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum.
Product code: JIT Calibrator, Secondary
Reason for recall: Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs.
Root cause tag: design
FDA root cause: Component design/selection
Action: On 1/22/2014, Customer Letters were sent via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue and advise them to discontinue use of the affected lot(s) and to inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. On 1/22/2014, Distributor Letters were sent via US Postal Service Priority Mail and/or FedEx overnight courier to US distributor consignees and instructed them to notify their consignees of the issue and actions.
Quantity in commerce: 1554 units domestically
Distribution: Nationwide
Product codes and lots: 0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1193-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1193-2014	Class III	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-12

Product code JIT

K121608Class IIVitros Immunodiagnostic Products 25-Oh Vitamin D Total Reagent Pack, Vitamin D Total CalibratorsOrtho-Clinical Diagnostics, Inc. / cleared 2013-02-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)