FDA Medical Device Recalls (openFDA)
Ortho-Clinical Diagnostics: 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.
- Recall number
- Z-1193-2014
- Recalling firm
- Ortho-Clinical Diagnostics
- 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.
- Status
- Terminated
- Initiated
- 2014-01-15
- Posted
- 2014-03-12
- Terminated
- 2017-04-03
- Reason
- 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
- 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
- 1554 units domestically
- Distribution
- Nationwide
- Lot, serial or model codes
- 0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110
- 510(k) numbers
- ["K121608"]
- PMA numbers
- not on file
- Product code
- JIT
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- 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