FDA Device recall Z-1193-2014
VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators
- FDA Device
- Class III
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class III recall of VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators by Ortho Clinical Diagnostics, citing ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Pr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1193-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-01-15 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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.
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.
Identifiers
| code_info | 0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1193-2014%22
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